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Implant Prosthetics

FDA UDI

Class II (US FDA UDI)

by PREAT Corporation

Identity

Trade Name
Implant Prosthetics FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Biomet 3i Certain®-compatible 4.1mm 30° Multi-Unit Abutment X 4mm FDA UDI
Model / Reference
9001786 FDA UDI
Description
Biomet 3i Certain®-compatible 4.1mm 30° Multi-Unit Abutment X 4mm FDA UDI

Identifiers

Catalog Number
9001786 FDA UDI
Primary DI / UDI-DI
00842092133569 FDA UDI
510(k) Number
K183518 FDA UDI
FDA Product Code
DZE FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3640 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

Yes

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

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

Cleared under the same submission

K183518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI 4cd54e15-32d9-4b1b-919e-b48d894bd456 37 fields · synced May 31, 2026