Identity
- Trade Name
- Papacarie FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Papacarie Kit - 1 ml syringe FDA UDI
- Model / Reference
- Papacarie Syringe FDA UDI
- Description
- Papacarie Kit - 1 ml syringe FDA UDI
Identifiers
- Catalog Number
- 610PAP100 FDA UDI
- Primary DI / UDI-DI
- 00858290006918 FDA UDI
- 510(k) Number
- K131376 FDA UDI
- FDA Product Code
- LBH 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 — 0.4 Milliliter FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Papacarie 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
K131376 also covers:
- FluoriMax 2.5% NaF Varnish — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 1 Bottle Kit Cotton Candy — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 12ML Bottle 2pk BG — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 12ML Bottle 2pk Mint — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 12ML Bottle 5pk BG — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish 12ML Bottle 5pk Mint — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish Flow Through — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish Flow Through — Elevate Oral Care, LLC
- FluoriMax 2.5% NaF Varnish Through — 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 66d4547d-c26a-4a76-bf16-10c18e3e0b6a 36 fields · synced Jun 9, 2026