Identity
- Trade Name
- Advantage Arrest FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle-3 pack FDA UDI
- Model / Reference
- 3 ml bottle-3 pk FDA UDI
- Description
- Advantage Arrest Silver Diamine Fluoride 38% 3 ml dropper bottle-3 pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858290006604 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
No
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 — 3 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.
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- Profisil — Kettenbach GmbH & Co. KG · Class II
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- 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 e8e11c6f-067a-4bfa-914f-59f2dd35a790 36 fields · synced Jun 9, 2026