Identity
- Trade Name
- GlasSpan Flexible Ceramic Bonding Tape FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Model / Reference
- TAPE FDA UDI
Identifiers
- Catalog Number
- 701771 FDA UDI
- Primary DI / UDI-DI
- 10723896011802 FDA UDI
- 510(k) Number
- K922673 FDA UDI
- FDA Product Code
- ELS FDA UDI
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3890 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental reinforcing fibre
GlasSpan Flexible Ceramic Bonding Tape by Practicon, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental reinforcing fibre.
- Infibra — BIOLOREN SRL · Class II
- everStick® — Gc America Inc. · Class II
- everStick® — Gc America Inc. · Class II
- ENFORCE FRC™ — G&H Wire Company, Inc. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- everStick® — Gc America Inc. · Class II
- Dentapreg® INTRO — ADM, a.s. · Class II
- GlasSpan Dental Fiber — GLASSPAN INC · Class II
Cleared under the same submission
K922673 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
- Practicon, Inc.
Sources (1)
- FDA UDI c5a63dbe-2eb7-453e-9e21-e9a20f92779a 34 fields · synced Jun 6, 2026