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Enamelast
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4523Ref 4528Ref 4822Ref 6908Ref 4352Ref 6907Ref 4819Ref 6911Ref 4343Ref 4353Ref 6909
Identity
- Trade Name
- Enamelast EUDAMEDFDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDICollagen antibody IVD, calibrator FDA UDI
- Device Name
- Enamelast, Gleo, Duraphat Fluoride Varnish EUDAMEDEnamelast 200pk Application Brushes FDA UDIEnamelast Unit Dose 50pk - Cool Mint FDA UDIEnamelast Syringe 20pk - Walterberry FDA UDIEnamelast Unit Dose 200pk - Orange Cream FDA UDIEnamelast Caramel 200pk FDA UDIEnamelast Unit Dose 50pk - Caramel FDA UDIEnamelast 200pk Walterberry FDA UDIEnamelast Unit Dose 200pk - Cool Mint FDA UDI
- Model / Reference
- 4353 EUDAMEDFDA UDI4523 EUDAMEDFDA UDI4343 EUDAMEDFDA UDI4822 EUDAMEDFDA UDI4819 EUDAMEDFDA UDI4528 EUDAMEDFDA UDI4352 EUDAMEDFDA UDI6908 EUDAMED6907 EUDAMED6911 EUDAMED6909 EUDAMED4529 FDA UDI
- Description
- Enamelast 200pk Application Brushes FDA UDIEnamelast Unit Dose 50pk - Cool Mint FDA UDIEnamelast Syringe 20pk - Walterberry FDA UDIEnamelast Unit Dose 200pk - Orange Cream FDA UDIEnamelast Caramel 200pk FDA UDIEnamelast Unit Dose 50pk - Caramel FDA UDIEnamelast 200pk Walterberry FDA UDIEnamelast Unit Dose 200pk - Cool Mint FDA UDI
Identifiers
- Catalog Number
- 4529 FDA UDI4353 FDA UDI4523 FDA UDI4343 FDA UDI4822 FDA UDI4819 FDA UDI4528 FDA UDI4352 FDA UDI
- Primary DI / UDI-DI
- 00883205102836 EUDAMEDFDA UDI00883205103178 EUDAMEDFDA UDI00883205102775 EUDAMEDFDA UDI00883205029089 EUDAMEDFDA UDI00883205028464 EUDAMEDFDA UDI00883205107916 EUDAMEDFDA UDI00883205102829 EUDAMEDFDA UDI00883205044099 EUDAMED00883205044075 EUDAMED00883205044129 EUDAMED00883205044105 EUDAMED00883205032171 FDA UDI
- Basic UDI-DI
- 0883205-TF327BE EUDAMED
- FDA Product Code
- DZN FDA UDILBH FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDICollagen antibody IVD, calibrator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDIClass II FDA UDI
- Regulation Number
- 872.4565 FDA UDI872.3260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Enamelast by Ultradent Products, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental coating, tooth-desensitizing, professional.
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- 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ultradent Products, Inc.
Sources (19)
- FDA UDI 6c1588d0-23e3-4315-80bb-bdc5e6d1b50a 35 fields · synced Jul 24, 2026
- FDA UDI 37d32a1a-5951-46af-bd1f-a8f2198d9b55 36 fields · synced May 29, 2026
- FDA UDI 31ae8a0b-cb46-4199-b4bb-0aa2513b3502 36 fields · synced May 30, 2026
- FDA UDI b5fa0eb4-217c-45bb-8a8f-77b34090ea3c 36 fields · synced May 30, 2026
- FDA UDI 5f4179c5-820a-4d54-b8cf-695dd4cdebdf 36 fields · synced May 30, 2026
- FDA UDI bd45d3a3-d736-4450-9d0a-e422f67d1d5a 36 fields · synced May 30, 2026
- FDA UDI f5bf3f52-fea1-4074-b9ae-50d7863377a9 36 fields · synced May 30, 2026
- FDA UDI 51bb8505-f80b-4cc0-b409-8100c5925f31 36 fields · synced May 30, 2026
- EUDAMED e93f6f02-9c08-487c-9e84-35ae181111e4 61 fields · synced Jul 8, 2026
- EUDAMED 4c1b61ea-43d1-44f5-a50c-979f1e91b3f4 61 fields · synced Jul 9, 2026
- EUDAMED 063738ad-6d48-407b-936b-25ba72e99ed5 61 fields · synced Jul 9, 2026
- EUDAMED ca412d89-9efc-4d82-bf24-b2c2ca86bf21 61 fields · synced Jul 10, 2026
- EUDAMED ff541ebc-1316-49b5-8ca3-4d99cfbaca28 61 fields · synced Jul 10, 2026
- EUDAMED 6f4074d5-a56f-47b2-902c-8268c4c6fa60 61 fields · synced Jul 11, 2026
- EUDAMED 11e64584-610f-4722-8145-924d5ac67bf7 61 fields · synced Jul 19, 2026
- EUDAMED 4c75e982-4e68-44cd-b549-c9ecfa4a0425 61 fields · synced Jul 19, 2026
- EUDAMED e0088155-25a7-4031-ae75-43a9b8a2dc1a 61 fields · synced Jul 24, 2026
- EUDAMED 50efec9c-bcfa-4d2e-8551-58af30b438ac 61 fields · synced Jul 24, 2026
- EUDAMED 33fe80e7-2eba-44fe-b6e8-2590d0401663 61 fields · synced Jul 24, 2026