ACH Medical Co., Ltd. (爱绮医疗器材) - Korean Dental Implant and Medical Device Manufacturer

Company Profile (Updated 2026)

ACH Medical Co., Ltd. is a dental and medical device manufacturer headquartered in Ulsan and Hwaseong-si, Gyeonggi-do, Republic of Korea (Address: Namyang-eup, Hwaseong-si, Gyeonggi-do, Rep. of Korea, 18255). Founded in 2008, the company has established itself as a professional dental implant enterprise integrating R&D, production, and sales.

Corporate Information:

- Full Name: ACH Medical Co., Ltd. (爱绮医疗器材)

- Founded: 2008

- Headquarters: Ulsan and Hwaseong-si, Gyeonggi-do, Republic of Korea

- Manufacturing Address: Namyang-eup, Hwaseong-si, Gyeonggi-do, 18255, Korea

- Business Type: Medical device manufacturer (dental implants and instruments)

- Industry: Dental Medical Devices / Oral Implantology

Corporate History:

- 2008: Company founded with mission to provide high-quality dental implant products

- 2009.04: Certified for 160 kinds of dental implant prosthetic components; obtained KFDA (Korea Ministry of Food and Drug Safety) manufacturing approval; designated as venture business (No. 20090108770); obtained CE Mark certification (Medical devices Class IIb)

- 2010.02: Registered dental implant surgical instrument sales

- 2011.03: Certified as R&D center affiliated company (No. 2011110466); designated as promising small and medium-sized business by Gyeongnam SME Administration Department

- 2012.04: Registered Kisses dental implant system with S.L.A surface treatment technology

- 2018: Received FDA 510(k) clearance for Kisses Plus Implant System (K172630)

- Ongoing: Continued collaboration with global research institutes and universities for product development

Core Products & Technology

G-Diff Implant System (Flagship Product Line)

Product Variants:

- IB-T (Internal Bone Level - Tapered): Morse tapered hex connection with platform switching; tapered body for excellent primary stability; 3-blade cutting edge with self-tapping function; rounded apex reduces bone perforation risk

- IB (Internal Bone Level): Standard bone level implant design

- IB-Mini: Narrow diameter implant for limited space applications

- IB-MT: Specialized design for specific clinical indications

- IT (Internal Tissue Level): Tissue level implant design

- Kisses: Implant system with S.L.A surface treatment (FDA 510(k) cleared as Kisses Plus)

Prosthetic Components:

- Abutment level components (plastic impression coping, temporary abutments)

- Fixture level components (pick-up impression coping, transfer impression coping)

- Overdenture level components (multi straight/angled abutments, ball abutments, locator attachments)

- Octa system components (octa impression coping, octa temporary abutment)

- Surgical components and mini implant kits

Surgical Instrument Systems

G-Diff Instrument Kits:

- Point drills, twist drills, cortical drills, drill stoppers

- Fixture drivers, drill extensions, depth gauges

- Torque wrenches, machine screw drivers, mount holders

- Specialized kits: GSK-FL (Full Kit), GSK-AL (Advanced Kit), GSK-PS (Prosthetic Kit)

- Step drills, side-cut drills, pilot drills, multi-drivers, octa drivers

Biomaterials

- Bone Graft Materials: For bone augmentation and alveolar ridge preservation procedures

- Barrier Membranes: For guided bone regeneration (GBR) procedures

Core Technologies

S.L.A. Surface Treatment (Sandblasted with Large grit and Acid-etched):

- Proprietary surface modification technology

- Large-grit sandblasting followed by acid etching

- Increases implant surface area for accelerated early osseointegration

- Optimized surface roughness for enhanced bone-implant contact

Precision Taper Connection Technology:

- Morse tapered hex connection design

- Provides high mechanical stability

- Excellent bacterial sealing performance

- Platform switching design reduces risk of inflammatory cell infiltration

- Contributes to marginal bone preservation and soft tissue attachment

Digital Guided Surgery Solutions:

- Compatible with mainstream digital intraoral scanners and tooth arrangement systems

- Supports minimally invasive Rapid restoration protocols

- Comprehensive digital workflow integration

Regulatory Certifications & Quality Standards

International Certifications

FDA 510(k) Clearance (USA):

- Kisses Plus Implant System cleared under K172630 (March 2018)

- Regulation Number: 21 CFR 872.3640 (Endosseous Dental Implant)

- Regulatory Class: Class II

- Product Codes: DZE, NHA

CE Mark Certification (European Union):

- Medical devices Class IIb certification obtained 2009

KFDA Approval (Korea):

- Korea Ministry of Food and Drug Safety manufacturing approval (2009)

- 160 kinds of dental implant prosthetic components certified

Quality Management:

- Material inspection and precision machining processes

- Acid etching surface treatment with process washing and full inspection

- Final automatic washing in clean room environment

- Gamma sterilization protocols

- Comprehensive inventory management and traceability systems

Global Market Presence

Export Markets

Distribution:

- Products distributed in over 7 countries globally

- Primary export markets include Turkey, with shipments of various implant components and surgical instruments

Export Product Range:

- Dental implant systems (PFX series, APMA, ATBA series)

- Titanium bases and abutments (ATB series, ATDA duplex abutments)

- Ball abutments and angled abutments

- Surgical instrument kits (GSK series)

Corporate Mission & Values

Mission Statement

"To provide more precise and safer implant solutions for global patients"

"To keep people well by supporting clinicians through high quality products and services"

Core Values:

- Quality assurance as first priority to satisfy all customer demands

- Continuous development of advanced products through collaboration with global research institutes and universities

- Pursuit of becoming a reliAble company providing innovative products and services

- Genuine Difference (G-Diff) philosophy in product design and manufacturing

Research & Development

R&D Capabilities

- Certified as R&D center affiliated company (2011)

- Collaboration with universities and research institutes for product development

- Focus on advanced surface treatment technologies and implant design optimization

- Long-term clinical case reporting (9+ year follow-up data available)

Contact Information

Headquarters & Manufacturing

Address: Namyang-eup, Hwaseong-si, Gyeonggi-do, Rep. of Korea, 18255
   TEL: +82-31-355-7110 (ext. 3)
   FAX: +82-31-355-6759
   Website: www.achmedical.com
   Email: info@achmedical.com

Regulatory Contact (USA)

ACHIMHAI Medical Corporation
   c/o Priscilla Chung, Regulatory Affairs Consultant
   LK Consulting Group USA, Inc.
   690 Roosevelt, Irvine, California 92620

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