UF(II) Anatomic Abutment

UF(II) Anatomic Abutment is a pre-manufactured dental implant component that supports a crown or bridge. It connects a root-form implant to the prosthetic restoration, with scalloped…

Registry build 21.09.26

UF(II) Anatomic Abutment is a pre-manufactured dental implant component that supports a crown or bridge. It connects a root-form implant to the prosthetic restoration, with scalloped margins that follow the gingival contour.

The abutments are made from titanium alloy and come in straight and angled configurations. The angled range includes 5 and 18 degree forms, providing different restorative orientations within the product family.

Fit and Supply

Different diameters and gingival heights accommodate the implant connection and surrounding tissue. The components are supplied nonsterile for steam sterilization before use and support single-tooth or multiple-tooth restorations.

15manufacturers in China registered for this device type
296catalogue numbers in this listing
5510(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 UF(II) Anatomic abutment
Listed by DIO Corporation, South Korea
FDA product code NHA
Device type Abutment, Implant, Dental, Endosseous
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Repacker / relabeller, Manufacturer, Exporter
510(k) K190048
Record published 2020-01-15
Record revised 2022-02-25 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
Distribution end date 2022-02-04

Catalogue Numbers

Catalogue numbers for UF(II) Anatomic abutment
Catalogue number Size Status
DCR 1570N In distribution
DUN 2555H In distribution
DLR 3570H In distribution
DLR 4570N Withdrawn
DAUN 2555N Withdrawn
DALR 4570H Withdrawn
DCR 5570H Withdrawn
DAUR 2555N Withdrawn
DLR 4570H Withdrawn
DUN 2570H Withdrawn
DACN 5570N Withdrawn
DALN 4570H Withdrawn
DUR 5570H Withdrawn
DALR 4555H Withdrawn
DALR 2555N Withdrawn
DMR 2540N Withdrawn
DPR 1540H Withdrawn
DLR 1555N Withdrawn
DLR 3570N Withdrawn
DMR 4540N Withdrawn
DALR 4570N Withdrawn
DUN 5555H Withdrawn
DUN 5570H Withdrawn
DALR 5555N Withdrawn
DCR 2570N Withdrawn
DUR 1570N Withdrawn
DAUR 3555H Withdrawn
DALR 3555H Withdrawn
DUR 2570N Withdrawn
DACR 5570N Withdrawn
DALR 3570H Withdrawn
DCR 4570N Withdrawn
DUR 4570H Withdrawn
DAUN 2570H Withdrawn
DMR 4570N Withdrawn
DLR 5555H Withdrawn
DAUR 5570H Withdrawn
DMR 1540H Withdrawn
DUR 3555H Withdrawn
DAUN 1555H Withdrawn
DCR 5570N Withdrawn
DMR 4555N Withdrawn
DLN 2570H Withdrawn
DLN 5555H Withdrawn
DACN 1555N Withdrawn
DACN 4555N Withdrawn
DACN 5570H Withdrawn
DLR 3555H Withdrawn
DALN 2555H Withdrawn
DAUN 5570H Withdrawn
DACR 4555N Withdrawn
DACN 3570H Withdrawn
DACR 4570H Withdrawn
DUN 1570H Withdrawn
DALR 2570N Withdrawn
DAUR 2570N Withdrawn
DALN 3555N Withdrawn
DAUR 1570N Withdrawn
DLR 4555H Withdrawn
DUN 2570N Withdrawn
DUN 2555N Withdrawn
DPR 5555N Withdrawn
DALN 1555N Withdrawn
DLR 1555H Withdrawn
DUN 3570H Withdrawn
DCR 4555H Withdrawn
DACR 1570H Withdrawn
DAUR 3570H Withdrawn
DUR 4570N Withdrawn
DPR 3570H Withdrawn
DPR 2555N Withdrawn
DCR 3570N Withdrawn
DALN 4555H Withdrawn
DCR 3570H Withdrawn
DALR 3570N Withdrawn
DACR 5555H Withdrawn
DALN 2570H Withdrawn
DAUN 3570N Withdrawn
DAUN 3570H Withdrawn
DAUN 3555H Withdrawn
DALN 4570N Withdrawn
DUN 4555N Withdrawn
DCN 4555N Withdrawn
DUR 3570N Withdrawn
DALN 5570H Withdrawn
DUR 5555H Withdrawn
DLR 2555N Withdrawn
DMR 5555N Withdrawn
DACN 1555H Withdrawn
DMR 2570H Withdrawn
DACR 2570N Withdrawn
DPR 5540N Withdrawn
DPR 2570N Withdrawn
DACN 2555N Withdrawn
DPR 1555H Withdrawn
DALN 4555N Withdrawn
DMR 5540N Withdrawn
DALN 2555N Withdrawn
DPR 4570N Withdrawn
DUN 5570N Withdrawn
DCN 1555H Withdrawn
DMR 4555H Withdrawn
DACN 1570N Withdrawn
DAUN 2570N Withdrawn
DMR 1540N Withdrawn
DALR 3555N Withdrawn
DMR 3555N Withdrawn
DACR 4570N Withdrawn
DLN 4570N Withdrawn
DMR 4570H Withdrawn
DCR 4555N Withdrawn
DUR 5570N Withdrawn
DMR 2555H Withdrawn
DALN 1570N Withdrawn
DPR 5555H Withdrawn
DACR 5555N Withdrawn
DUR 4555N Withdrawn
DPR 3555N Withdrawn
DLR 1570N Withdrawn
DCN 5570N Withdrawn
DUR 3555N Withdrawn
DCN 3555H Withdrawn
DPR 1540N Withdrawn
DACN 3555H Withdrawn
DCN 3570N Withdrawn
DMR 2570N Withdrawn
DPR 1555N Withdrawn
DLR 5570H Withdrawn
DUN 4555H Withdrawn
DAUN 5555N Withdrawn
DACR 3555N Withdrawn
DAUN 4555N Withdrawn
DAUN 4555H Withdrawn
DALR 2555H Withdrawn
DAUR 1555N Withdrawn
DMR 2540H Withdrawn
DAUR 5570N Withdrawn
DAUR 4555N Withdrawn
DUR 2555H Withdrawn
DACN 4555H Withdrawn
DALR 1570H Withdrawn
DPR 1570N Withdrawn
DPR 4540H Withdrawn
DLN 3570H Withdrawn
DLR 3555N Withdrawn
DLN 1555N Withdrawn
DAUR 2570H Withdrawn
DCN 4570N Withdrawn
DLN 1570H Withdrawn
DALR 5570H Withdrawn
DACN 2570N Withdrawn
DLN 1555H Withdrawn
DUN 1570N Withdrawn
DLR 5570N Withdrawn
DAUN 5555H Withdrawn
DCN 2555N Withdrawn
DACR 1555H Withdrawn
DALR 1570N Withdrawn
DALR 1555N Withdrawn
DALN 5555N Withdrawn
DLR 2570N Withdrawn
DUR 2570H Withdrawn
DUN 4570N Withdrawn
DACR 1555N Withdrawn
DAUN 4570N Withdrawn
DACR 3555H Withdrawn
DAUN 5570N Withdrawn
DALR 1555H Withdrawn
DCR 1555N Withdrawn
DUN 3570N Withdrawn
DMR 1570H Withdrawn
DLR 2570H Withdrawn
DACR 1570N Withdrawn
DPR 2540H Withdrawn
DCR 5555H Withdrawn
DCN 2555H Withdrawn
DACN 1570H Withdrawn
DPR 4540N Withdrawn
DPR 2540N Withdrawn
DLR 2555H Withdrawn
DLN 1570N Withdrawn
DLN 2555H Withdrawn
DPR 5540H Withdrawn
DCN 3555N Withdrawn
DMR 5555H Withdrawn
DUR 1570H Withdrawn
DCN 2570H Withdrawn
DAUR 4570H Withdrawn
DUR 1555N Withdrawn
DACR 4555H Withdrawn
DACN 5555N Withdrawn
DCN 4570H Withdrawn
DUR 2555N Withdrawn
DUN 1555N Withdrawn
DALR 2570H Withdrawn
DAUR 3570N Withdrawn
DCR 2555N Withdrawn
DLN 4570H Withdrawn
DACN 5555H Withdrawn
DLR 5555N Withdrawn
DPR 2555H Withdrawn
DCN 4555H Withdrawn
DAUR 3555N Withdrawn
DLN 3555H Withdrawn
DAUR 4570N Withdrawn
DACR 2555N Withdrawn
DAUN 1570H Withdrawn
DCN 1570H Withdrawn
DMR 3555H Withdrawn
DAUR 1555H Withdrawn
DUR 5555N Withdrawn
DACR 5570H Withdrawn
DUN 3555N Withdrawn
DAUN 1570N Withdrawn
DALN 3555H Withdrawn
DAUN 1555N Withdrawn
DUN 3555H Withdrawn
DALR 5555H Withdrawn
DALN 1555H Withdrawn
DCR 2555H Withdrawn
DCR 3555N Withdrawn
DMR 3540N Withdrawn
DACR 2570H Withdrawn
DPR 4555H Withdrawn
DACN 3570N Withdrawn
DCN 5555H Withdrawn
DACR 3570N Withdrawn
DPR 4555N Withdrawn
DUN 1555H Withdrawn
DCR 2570H Withdrawn
DUR 1555H Withdrawn
DLR 1570H Withdrawn
DACN 4570N Withdrawn
DCN 3570H Withdrawn
DLN 2570N Withdrawn
DPR 3555H Withdrawn
DALN 3570H Withdrawn
DPR 4570H Withdrawn
DCR 4570H Withdrawn
DCR 3555H Withdrawn
DAUN 3555N Withdrawn
DLN 4555H Withdrawn
DMR 3570H Withdrawn
DMR 2555N Withdrawn
DCN 1555N Withdrawn
DMR 1555N Withdrawn
DAUR 2555H Withdrawn
DUR 3570H Withdrawn
DPR 2570H Withdrawn
DLN 5570H Withdrawn

Showing 250 of 296 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
K220253 2023-08-18
K193404 2020-05-18
K192263 2020-02-21
K190048 2019-09-30
K181037 2018-12-21

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