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PiezoImplant System

FDA UDI

Class II (US FDA UDI)

by Rex Implants, Inc

Identity

Trade Name
PiezoImplant System FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Custom Abutment Blank TL 2.9 FDA UDI
Model / Reference
Custom Abutment Blank TL 2.9 FDA UDI
Description
Custom Abutment Blank TL 2.9 FDA UDI

Identifiers

Catalog Number
R2-38 FDA UDI
Primary DI / UDI-DI
D894R2380 FDA UDI
510(k) Number
K211872 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

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

Dimensions & Sizes

Size
Outer Diameter — 3.5 Millimeter FDA UDI

PiezoImplant System by Rex Implants, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K211872 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rex Implants, Inc

Sources (1)

  • FDA UDI 499ca98a-973a-4c1c-b8a2-0106e8f744ab 38 fields · synced May 29, 2026