Identity
- Trade Name
- Gleo EUDAMEDFDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Enamelast, Gleo, Duraphat Fluoride Varnish EUDAMEDGleo Varnish 10ml Tube Kit Berry FDA UDI
- Model / Reference
- 5831 EUDAMEDFDA UDI
- Description
- Gleo Varnish 10ml Tube Kit Berry FDA UDI
Identifiers
- Catalog Number
- 5831 FDA UDI
- Primary DI / UDI-DI
- 00883205042361 EUDAMEDFDA UDI
- Basic UDI-DI
- 0883205-TF327BE EUDAMED
- FDA Product Code
- LBH FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 coating, tooth-desensitizing, professional
Gleo by Ultradent Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing, professional.
- MEDICOM DURAFLOR ULTRA — AMD Medicom Inc · Class II
- Profisil — Kettenbach GmbH & Co. KG · Class II
- Profisil — Kettenbach GmbH & Co. KG · Class II
- Wonderful Dental — Roses and Rubies, LLC · Class II
- Young — YOUNG DENTAL MANUFACTURING I, LLC · Class II
- SurgiMac — Surgimac LLC · Class II
- TastyTooth — PREMIER DENTAL PRODUCTS COMPANY · Class II
- Wonderful Dental — Roses and Rubies, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Ultradent Products, Inc.
Sources (2)
- FDA UDI dce9ae86-3c4f-4724-8c34-5ff76aea343e 36 fields · synced Jul 30, 2026
- EUDAMED 84895a67-b3d1-44f9-b395-c1d9d4ded3b4 61 fields · synced Jul 30, 2026