Identity
- Trade Name
- BEYOND® BlueSeal® Gingival Protection (5 pack) FDA UDI
- Generic Name
- Gingiva bleaching protector FDA UDI
- Model / Reference
- BY-PD02205 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857848007209 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Gingiva bleaching protector FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingiva bleaching protector
BEYOND® BlueSeal® Gingival Protection (5 pack) by Beyond International Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Gingiva bleaching protector.
- Mavrik Dental System — Mavrik Dental System Inc. · Class I
- CHAIRSIDE — Zest Anchors, LLC · Class I
- BEYOND® BlueSeal® Gingival Protection Twin Pack — Beyond International Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Beyond International Inc.
Sources (1)
- FDA UDI 1a47f8f6-fc6d-4855-862c-3e9d97cb8025 32 fields · synced Jun 9, 2026