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GlasSpan Flexible Ceramic Bonding Material Standard Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- GlasSpan Flexible Ceramic Bonding Material Standard Kit FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Contains (3) GlasSpan Flexible Ceramic Bonding Rope Small (3) GlasSpan Flexible Ceramic Bonding Rope Medium (3)GlasSpan Flexible Ceramic Bonding Rope large and (3) GlasSpan Flexible Ceramic Bonding Tape FDA UDI
- Model / Reference
- STANDARD KIT FDA UDI
- Description
- Contains (3) GlasSpan Flexible Ceramic Bonding Rope Small (3) GlasSpan Flexible Ceramic Bonding Rope Medium (3)GlasSpan Flexible Ceramic Bonding Rope large and (3) GlasSpan Flexible Ceramic Bonding Tape FDA UDI
Identifiers
- Catalog Number
- 701770 FDA UDI
- Primary DI / UDI-DI
- 00723896011737 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
Yes
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 Material Standard Kit 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
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
- Practicon, Inc.
Sources (1)
- FDA UDI de91a939-5c89-42fb-9a47-e3b7569ac9a3 35 fields · synced May 30, 2026