Identity
- Trade Name
- Maximum Cure FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. 7g Maximum Cure Filled sealant part A with fluoride. This is the filled version of this sealant. This product contains Fluoride. FDA UDI
- Model / Reference
- MCF7AF FDA UDI
- Description
- Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. 7g Maximum Cure Filled sealant part A with fluoride. This is the filled version of this sealant. This product contains Fluoride. FDA UDI
Identifiers
- Catalog Number
- MCF7AF FDA UDI
- Primary DI / UDI-DI
- D798MCF7AF0 FDA UDI
- 510(k) Number
- K894566 FDA UDI
- FDA Product Code
- DYH FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3750 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
Category: Dental composite resin
Maximum Cure by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K894566 also covers:
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 4f3fcd31-38b8-439c-9ca8-057e5fd21474 37 fields · synced May 31, 2026