Renew Universal

FDA UDI

Class II (US FDA UDI)

by Prevest Denpro Limited

Identity

Trade Name: Renew Universal FDA UDI
Generic Name: Dental acrylic resin kit FDA UDI
Model / Reference: Economy Pack FDA UDI

Identifiers

Catalog Number: 10019 FDA UDI
Primary DI / UDI-DI: D96710019 FDA UDI
510(k) Number: K231696 FDA UDI
FDA Product Code: KLE FDA UDI
GMDN Term: Dental acrylic resin kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Category: Dental acrylic resin kit

Renew Universal by Prevest Denpro Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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AxioBond 5 — Axiodent Inc. · Class II
AxioBond DC — Axiodent Inc. · Class II
AxioBond Universal — Axiodent Inc. · Class II
The Orthodontic Store — Young Innovations, Inc. · Class II

Cleared under the same submission

K231696 also covers:

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: Prevest Denpro Limited

Sources (1)

FDA UDI 44230b97-7dab-4def-a034-e412c3fa37a9 34 fields · synced Jun 1, 2026