Identity
- Trade Name
- Advantage Arrest FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 30pk FDA UDI
- Model / Reference
- 635GE3000 FDA UDI
- Description
- Advantage Arrest Silver Diamine Fluoride 38% GEL Unit Dose Ampoule with applicators 30pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858290006802 FDA UDI
- 510(k) Number
- K102973 FDA UDI
- FDA Product Code
- PHR FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Dimensions & Sizes
- Size
- Total Volume — 0.1 Milliliter FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Advantage Arrest by Elevate Oral Care, LLC — Class II — FDA UDI — listed in FDA GUDID — 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
Cleared under the same submission
K102973 also covers:
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
- Advantage Arrest — Elevate Oral Care, LLC
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
- Elevate Oral Care, LLC
Sources (1)
- FDA UDI 69587d9a-2a33-45d0-9543-cb59a9e1d218 36 fields · synced Jun 9, 2026