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: Straumann® BL-compatible NC X 4.5mm Non-Engaging Titanium Base FDA UDI
Model / Reference: 8001559 FDA UDI
Description: Straumann® BL-compatible NC X 4.5mm Non-Engaging Titanium Base FDA UDI

Identifiers

Catalog Number: 8001559 FDA UDI
Primary DI / UDI-DI: 00842092118320 FDA UDI
FDA Product Code: NHA FDA UDI
DZE FDA UDI
GMDN Term: Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3630 FDA UDI
872.3640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant suprastructure, permanent, preformed Dental prosthesis/implant abutment screw

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

Similar devices

Also classified as Dental prosthesis/implant abutment screw.

Azure — TERRATS MEDICAL SL. · Class II
Inclusive — PRISMATIK DENTALCRAFT, INC. · Class II
KLOCKNER — SOADCO, S.L. · Class II
DYNAMIC ABUTMENT SOLUTIONS — TALLADIUM ESPAÑA SL · Class II
INNO Submerged Implant System-Cemented Abutment — Cowellmedi Co., Ltd · Class II
MEDENTiKA — Medentika GmbH · Class II
Azure — TERRATS MEDICAL SL. · Class II
Recharge Kit w/ POC, TiLobe — SMART DENTURE CONVERSIONS, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: PREAT Corporation

Sources (1)

FDA UDI a15b7bd2-4fb5-48ff-83c8-10cf0d62cfb2 35 fields · synced May 31, 2026