Implant-One

300 Series Denture Retaining Abutment, 17 Degree Angled Retention, 2.5mm Cuff Height, No Hex. Includes screw and denture retention cap.

Registry build 21.09.26
15manufacturers in China registered for this device type
416catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NHA
Manufacturer City Province Registered as Device types
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Modern Dental Laboratory (DG) Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Exceldent Dental Technology Development Co., Ltd. Zhuhai Guangdong Contract manufacturer 12
DTS Digital Dental LAB Shenzhen Guangdong Contract manufacturer 11
KTJ Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shimmer Computerized Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 10
Zhuhai Crystal Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 9
NEW Perfect Dental LAB Shenzhen Guangdong Contract manufacturer 8
Shenzhen Jiahong Dental Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Trausim Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 3
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
CBD Dental LAB, Inc Shenzhen Guangdong Manufacturer 11

Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous

Record

Regulatory record for Implant-One
Listed by Implant Logistics, Inc., United States
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
510(k) K173701
Record published 2020-08-11
Record revised 2026-04-15 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date, serial number
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for Implant-One
Catalogue number Size Status
HCW-0550-00 In distribution
IT2410 In distribution
MUA-0335-17M In distribution
IT239-30 In distribution
IT135-40 In distribution
APT-0340-00 In distribution
IT235-70 In distribution
ACM-0115-AR In distribution
ABL-0430-00 In distribution
IT235-30 In distribution
IT140-20 In distribution
APT-0310-00 In distribution
APT-0405-30 In distribution
ALR-0505-00 In distribution
HCW-0430-00 In distribution
IT220-20 In distribution
IT221-40 In distribution
ALR-0510-00 In distribution
APT-0320-30 In distribution
IT230-20 In distribution
IT237-30 In distribution
ATB-0325-01 In distribution
ALR-0420-00 In distribution
IT142-30 In distribution
HHS-0500-00 In distribution
APT-0310-15 In distribution
AWP-0440-00 In distribution
AWP-0350-00 In distribution
ABL-0530-00 In distribution
1123-3302-00 In distribution
ATM-0520-00 In distribution
APT-0410-15 In distribution
ATB-0405-00 In distribution
HCS-0550-00 In distribution
ALR-0370-00 In distribution
ATB-0505-00 In distribution
IT230-10 In distribution
APT-0520-30 In distribution
IT125-20 In distribution
IT137-10 In distribution
IT130-00 In distribution
ATM-0530-00 In distribution
ALR-0540-00 In distribution
IT221-50 In distribution
IT121-20 In distribution
IT220-10 In distribution
IT121-50 In distribution
HCN-0530-00 In distribution
APT-0305-30 In distribution
1123-3301-00 In distribution
IT133-10 In distribution
IT242-30 In distribution
APT-0440-30 In distribution
ACM-0515-AR In distribution
ALR-0340-00 In distribution
IT133-30 In distribution
APT-0305-15 In distribution
MUA-0305-00M In distribution
MUA-0345-VCM In distribution
AS-310 In distribution
IT220-05 In distribution
MUA-0505-00M In distribution
AS-340 In distribution
HCW-0450-00 In distribution
APT-0520-15 In distribution
ATM-0320-00 In distribution
IT140-40 In distribution
ATM-0410-00 In distribution
1123-4807-00 In distribution
MUA-0425-30M In distribution
APT-0305-00 In distribution
APT-0510-15 In distribution
ALR-0440-00 In distribution
IT138-30 In distribution
1123-4106-00 In distribution
IT138-50 In distribution
IT133-50 In distribution
IT233-50 In distribution
AWP-0520-00 In distribution
ALR-0450-00 In distribution
IT221-10 In distribution
1123-4803-00 In distribution
HCS-0530-00 In distribution
ABL-0440-00 In distribution
APT-0440-15 In distribution
APT-0340-15 In distribution
IT235-20 In distribution
HCS-0410-00 In distribution
AWP-0305-00 In distribution
HCN-0350-00 In distribution
ALR-0305-00 In distribution
HCN-0450-00 In distribution
1123-4104-00 In distribution
ABL-0520-00 In distribution
IT220-50 In distribution
MUA-0530-00M In distribution
AWP-0430-00 In distribution
IT1410 In distribution
IT242-50 In distribution
APT-0330-30 In distribution
1123-4103-00 In distribution
ATB-0425-00 In distribution
IT139-30 In distribution
ABL-0350-00 In distribution
IT120-40 In distribution
IT120-05 In distribution
MUA-0535-30M In distribution
HCS-0310-00 In distribution
1123-4804-00 In distribution
HCS-0350-00 In distribution
IT221-20 In distribution
ABL-0420-00 In distribution
HHS-0500-01 In distribution
MUA-0345-HCM In distribution
ATB-0525-00 In distribution
APT-0430-00 In distribution
ALR-0530-00 In distribution
IT130-10 In distribution
APT-0450-00 In distribution
APT-0505-30 In distribution
ATB-0315-01 In distribution
APT-0350-15 In distribution
IT137-30 In distribution
MUA-0410-00M In distribution
HHS-0400-00 In distribution
IT133-40 In distribution
HCN-0310-00 In distribution
ACM-0415-AR In distribution
HCS-0450-00 In distribution
IT135-70 In distribution
ALR-0470-00 In distribution
ATM-0550-00 In distribution
AS-300 In distribution
IT135-20 In distribution
1123-3307-00 In distribution
APT-0510-30 In distribution
MUA-0340-00M In distribution
IT238-50 In distribution
APT-0450-30 In distribution
MUA-0310-00M In distribution
APT-0410-00 In distribution
1123-4801-00 In distribution
HCS-0430-00 In distribution
HCN-0320-00 In distribution
ATM-0350-00 In distribution
APT-0350-00 In distribution
THS-1635-23 In distribution
MUA-0350-00M In distribution
AS-460 In distribution
APT-0540-15 In distribution
APT-0350-30 In distribution
IT240-30 In distribution
IT230-05 In distribution
ALR-0560-00 In distribution
APT-0540-00 In distribution
APT-0505-00 In distribution
HCW-0330-00 In distribution
APT-0520-00 In distribution
1123-3303-00 In distribution
IT237-10 In distribution
APT-0420-15 In distribution
HHS-0300-01 In distribution
ATB-0515-00 In distribution
IT121-30 In distribution
AST-0400-00 In distribution
HCN-0410-00 In distribution
HCN-0430-00 In distribution
AST-0300-00 In distribution
IT235-50 In distribution
APT-0320-15 In distribution
CSR-0400-00 In distribution
MUA-0330-00M In distribution
MUA-0425-17M In distribution
APT-0310-30 In distribution
IT233-20 In distribution
MUA-0335-30M In distribution
AWP-0510-00 In distribution
ACM-0315-AR In distribution
MUA-0435-17M In distribution
IT130-20 In distribution
HCN-0570-00 In distribution
1123-3306-00 In distribution
1123-4802-00 In distribution
APT-0420-30 In distribution
IT120-20 In distribution
IT233-30 In distribution
IT135-50 In distribution
ATM-0420-00 In distribution
HHS-0300-00 In distribution
IT133-20 In distribution
MUA-0540-00M In distribution
IT120-50 In distribution
1123-3305-00 In distribution
ABL-0450-00 In distribution
MUA-0345-TB In distribution
ALR-0460-00 In distribution
AWP-0540-00 In distribution
IT139-50 In distribution
THS-0300-01 In distribution
ABL-0540-00 In distribution
AWP-0450-00 In distribution
IT244-05 In distribution
HHS-0400-01 In distribution
ATM-0450-00 In distribution
MUA-0420-00M In distribution
1123-4101-00 In distribution
AWP-0420-00 In distribution
IT130-30 In distribution
ALR-0430-00 In distribution
APT-0410-30 In distribution
1123-4806-00 In distribution
CSR-0300-00 In distribution
APT-0405-00 In distribution
APT-0440-00 In distribution
IT220-40 In distribution
AWP-0320-00 In distribution
IT140-50 In distribution
IT239-50 In distribution
ABL-0550-00 In distribution
APT-0510-00 In distribution
IT140-30 In distribution
ATB-0305-01 In distribution
AST-0500-00 In distribution
MUA-0440-00M In distribution
IT130-05 In distribution
MUA-0520-00M In distribution
APT-0320-00 In distribution
ATM-0540-00 In distribution
ACM-0215-AR In distribution
IT125-10 In distribution
MUA-0550-00M In distribution
HCN-0470-00 In distribution
AS-350 In distribution
IT233-40 In distribution
IT220-30 In distribution
ALR-0520-00 In distribution
IT235-60 In distribution
AWP-0340-00 In distribution
IT121-40 In distribution
IT235-40 In distribution
HCN-0510-00 In distribution
APT-0420-00 In distribution
IT142-50 In distribution
AS-280 In distribution
IT121-10 In distribution
IT135-60 In distribution
IT230-00 In distribution
ALR-0310-00 In distribution
APT-0340-30 In distribution
MUA-0430-00M In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MEDENTiKA Medentika GmbH 2,553
LW Vis Abutment Ossvis Co., Ltd. 2,520
Dess dental smart solutions Terrats Medical SL 1,715
Locator Zest Anchors, LLC 1,643
NobelProcera® Nobel Biocare AB 1,526
Azure Terrats Medical SL 1,360
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 1,308
LW Vis Abutment SET Ossvis Co., Ltd. 1,260
Abutment, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,240
Healing Abutment Megagen Implant Co., Ltd. 1,218
Chaorum Implant System Medimecca Co Ltd 1,084
OT Equator Rhein 83 SRL 1,051

Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K231455 2023-08-15
K212394 2023-03-23

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer