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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
Hiossen® HG-compatible Mini 17° Multi-Unit Abutment X 2.5mm FDA UDI
Model / Reference
8005080 FDA UDI
Description
Hiossen® HG-compatible Mini 17° Multi-Unit Abutment X 2.5mm FDA UDI

Identifiers

Catalog Number
8005080 FDA UDI
Primary DI / UDI-DI
00842092118979 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
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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental implant suprastructure, permanent, preformed

Implements a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration, providing an abutment screw(s) for easy replacement during cleaning cycles. The Implant Prosthetics is a prefabricated device designed to ensure seamless integration with existing implants and prosthetics.

Similar devices

Also classified as Dental implant suprastructure, permanent, preformed.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PREAT Corporation

Sources (1)

  • FDA UDI 7c765919-0d54-4ba6-87da-1a1bc8f8ea7a 35 fields · synced Jul 25, 2026