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Dentin Classic Implants

FDA UDI

Class II (US FDA UDI)

by Dentin Implants Technologies Ltd

Identity

Trade Name
DENTIN CLASSIC IMPLANTS FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
Classic dental implant D=4.2mm, L=8mm FDA UDI
Model / Reference
PRA-0842 FDA UDI
Description
Classic dental implant D=4.2mm, L=8mm FDA UDI

Identifiers

Primary DI / UDI-DI
07290113350380 FDA UDI
510(k) Number
K120530 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Screw endosteal dental implant, two-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Screw endosteal dental implant, two-piece

Dentin Classic Implants by Dentin Implants Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw endosteal dental implant, two-piece.

Cleared under the same submission

K120530 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentin Implants Technologies Ltd

Sources (1)

  • FDA UDI 654b26e6-8195-44f1-bbad-01a07fe45759 34 fields · synced May 30, 2026