PiezoImplant System

FDA UDI

Class II (US FDA UDI)

by Rex Implants, Inc

Identity

Trade Name: PiezoImplant System FDA UDI
Generic Name: Dental implant system FDA UDI
Device Name: REX TL 2.9 H15 Assembly with rough transcortical surface (Implant, Retention Screw TL 2.9, Transfer / Straight Abutment TL 2.9) packaged with Cover Screw TL 2.9 FDA UDI
Model / Reference: REX TL 2.9 H15 R FDA UDI
Description: REX TL 2.9 H15 Assembly with rough transcortical surface (Implant, Retention Screw TL 2.9, Transfer / Straight Abutment TL 2.9) packaged with Cover Screw TL 2.9 FDA UDI

Identifiers

Catalog Number: T2-15R FDA UDI
Primary DI / UDI-DI: D894T215R0 FDA UDI
510(k) Number: K211872 FDA UDI
FDA Product Code: NRQ FDA UDI
GMDN Term: Dental implant system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3640 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 15 Millimeter FDA UDI
Width — 5 Millimeter FDA UDI

Category: Dental implant system

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

Similar devices

Also classified as Dental implant system.

Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
Implant Regular — BIO CONCEPT Co., Ltd. · Class II
TRI — Tri Dental Implants Int. AG · Class II

Cleared under the same submission

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

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

Manufacturer

Manufacturer: Rex Implants, Inc

Sources (1)

FDA UDI 4693a196-bd06-4f46-83f8-89bc965bce2a 38 fields · synced May 30, 2026