Ascent OL5 Barrier Sleeve

FDA UDI

Class II (US FDA UDI)

by Cao Group, Inc.

Identity

Trade Name: Ascent OL5 Barrier Sleeve FDA UDI
Generic Name: Dental/surgical polymerization lamp FDA UDI
Device Name: Single-use barrier sleeve for use with the Ascent OL5 dental curing light. FDA UDI
Model / Reference: 02443 FDA UDI
Description: Single-use barrier sleeve for use with the Ascent OL5 dental curing light. FDA UDI

Identifiers

Primary DI / UDI-DI: 00872320003401 FDA UDI
510(k) Number: K020057 FDA UDI
FDA Product Code: EBZ FDA UDI
GMDN Term: Dental/surgical polymerization lamp FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental/surgical polymerization lamp

Ascent OL5 Barrier Sleeve by Cao Group, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Coltolux — Coltene/Whaledent Inc. · Class II
VALO — ULTRADENT PRODUCTS, INC. · Class II

Cleared under the same submission

K020057 also covers:

Ascent OL5 Curing Light — CAO GROUP, INC.

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: Cao Group, Inc.

Sources (1)

FDA UDI eaddc074-fbf0-4cd6-8cf7-4d7cdd64dec9 35 fields · synced Jun 6, 2026