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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=3.8mm, L=10mm FDA UDI
Model / Reference
PRA-1038 FDA UDI
Description
Classic dental implant D=3.8mm, L=10mm FDA UDI

Identifiers

Primary DI / UDI-DI
07290113350342 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 are a type of screw endosteal dental implant that provides support and retention for dental prostheses. Made from alloplastic materials such as titanium, stainless steel, or ceramic, these implants have been developed to be a reliable and durable option for patients.

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 5b97d445-68e5-4bca-87e0-a1b07cb409d7 34 fields · synced Jul 21, 2026