Identity
- Trade Name
- Candy Apple Red Polymer FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Tinted Opaque Powder FDA UDI
- Model / Reference
- 25 FDA UDI
- Description
- Tinted Opaque Powder FDA UDI
Identifiers
- Catalog Number
- 25 FDA UDI
- Primary DI / UDI-DI
- D85125 FDA UDI
- 510(k) Number
- K974727 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
Category: Dental appliance fabrication material, resin
Candy Apple Red Polymer by J.B.C and Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, resin.
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Cleared under the same submission
K974727 also covers:
- 123 Maroon Tinted Monomer — J.B.C and Co.
- Amber Tinted Monomer — J.B.C and Co.
- Aqua Sparkle Polymer — J.B.C and Co.
- Aztec Gold Sparkle Polymer — J.B.C and Co.
- BM Medium Green Tinted Monomer — J.B.C and Co.
- BM Medium Purple Tinted Monomer — J.B.C and Co.
- Bleached White Tooth Shade Polymer BS2 — J.B.C and Co.
- Bleached White Tooth Shade Polymer BS4 — J.B.C and Co.
- Caribbian Blue Tinted Monomer — J.B.C and Co.
- Carnival Blue Sparkle Polymer — J.B.C and Co.
- Chocolate Brown Polymer — J.B.C and Co.
- Cobalt Blue Tinted Monomer — J.B.C and Co.
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
- J.B.C and Co.
Sources (1)
- FDA UDI 90183543-6333-411d-8d2f-cfd5d92c3178 36 fields · synced Jun 6, 2026