MEDENTiKA

PreFace abutment

Registry build 21.09.26
2manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PNP
Manufacturer City Province Registered as Device types
Exceldent Dental Technology Development Co., Ltd. Zhuhai Guangdong Contract manufacturer 12
Shimmer Computerized Dental Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 10

Record

Regulatory record for MEDENTiKA
Listed by Medentika GmbH, Germany
FDA product code PNP
Device type Dental Abutment Design Software For Dental Laboratory
Device class Class 2
Regulation 21 CFR 872.3630
Establishment Specification developer, Manufacturer
Record published 2026-06-18

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MEDENTiKA
Catalogue number Size Status
N 9030RV10 In distribution
EV 9010RV10 In distribution
T 902016RV10 In distribution
L 9020RV10 In distribution
EV 902016RV10 In distribution
H 901016RV10 In distribution
L 9000RV10 In distribution
I 902016RV10 In distribution
S 9020RV10 In distribution
N 9010RV10 In distribution
H 902016RV10 In distribution
I 9000RV10 In distribution
F 9010RV10 In distribution
EV 9020RV10 In distribution
EV 903016RV10 In distribution
R 9000RV10 In distribution
S 900016RV10 In distribution
L 9010RV10 In distribution
EV 9040RV10 In distribution
E 9020RV10 In distribution
E 903016RV10 In distribution
R 9010RV10 In distribution
H 9000RV10 In distribution
T 9000RV10 In distribution
F 9000RV10 In distribution
S 9030RV10 In distribution
E 901016RV10 In distribution
N 902016RV10 In distribution
MG 9000RV10 In distribution
R 901016RV10 In distribution
K 902016RV10 In distribution
EV 9030RV10 In distribution
H 9010RV10 In distribution
L 901016RV10 In distribution
R 900016RV10 In distribution
E 902016RV10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IPD Implant Protesis Dental 2004 SL 317
BruxZir® Prismatik Dentalcraft, Inc. 62
Preat Preat Corporation 46
Cerec Tessera Degudent Gmbh 15
BioHorizons Biohorizons Implant Systems Inc. 10
Nobel Biocare N1™ Nobel Biocare AB 10
CAD/CAM Software Sirona Dental Systems Gmbh 9
Dental Abutment Design Software For Dental Laboratory Nobel Biocare AB 7
Cerec Degudent Gmbh 6
Preat Implant Prosthetics Preat Corporation 4
DTX Studio™ Lab Nobel Biocare AB 4
AbutmentCAD Exocad Gmbh 4

Showing 12 of 19. All products under Dental Abutment Design Software For Dental Laboratory

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