← Back to catalogue

Branemark

FDA UDI

Class II (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Branemark FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Neoss®-compatible 4.1mm Straight Multi-Unit Abutment X 1.0mm FDA UDI
Model / Reference
8004175 FDA UDI
Description
Neoss®-compatible 4.1mm Straight Multi-Unit Abutment X 1.0mm FDA UDI

Identifiers

Catalog Number
8004175 FDA UDI
Primary DI / UDI-DI
00842092115190 FDA UDI
510(k) Number
K142118 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Branemark by PREAT Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K142118 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI 0faa31a4-6987-4e7e-bfb9-507439b2af75 37 fields · synced May 31, 2026