Identity
- Trade Name
- ProSeal FDA UDI
- Generic Name
- Dental pit/fissure sealant FDA UDI
- Device Name
- LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a Reliance Black Light or a simple portable (UV) light. Cures using a 468nm LED Light. 6ml bottle LED ProSeal FDA UDI
- Model / Reference
- LEDPRO FDA UDI
- Description
- LED PRO SEAL® is intended for use as an enamel surface sealant around orthodontic brackets. LED PRO SEAL® can be illuminated or“revealed” on the tooth surface to check application using a Reliance Black Light or a simple portable (UV) light. Cures using a 468nm LED Light. 6ml bottle LED ProSeal FDA UDI
Identifiers
- Catalog Number
- LEDPRO FDA UDI
- Primary DI / UDI-DI
- D798LEDPRO0 FDA UDI
- 510(k) Number
- K073243 FDA UDI
- FDA Product Code
- EBD FDA UDI
- GMDN Term
- Dental pit/fissure sealant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3310 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 pit/fissure sealant
ProSeal by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073243 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 |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI acf08673-5a20-48dc-acff-9f68933b6a8d 37 fields · synced May 30, 2026