Identity
- Trade Name
- Neoss Implant System FDA UDI
- Generic Name
- Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
- Device Name
- NeoGen Cape Spacer 1.5 mm, Neoss SP FDA UDI
- Model / Reference
- 64081 FDA UDI
- Description
- NeoGen Cape Spacer 1.5 mm, Neoss SP FDA UDI
Identifiers
- Catalog Number
- 64081 FDA UDI
- Primary DI / UDI-DI
- 05060440335549 FDA UDI
- FDA Product Code
- DZL FDA UDI
- GMDN Term
- Dental regeneration membrane fixation tack, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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 regeneration membrane fixation tack, non-bioabsorbable
Neoss Implant System by Neoss, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental regeneration membrane fixation tack, non-bioabsorbable.
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- GBR System — Surgident · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class II
- GBR Screw — DENTIS CO. , LTD · Class II
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
- Neoss, Ltd.
Sources (1)
- FDA UDI c1f4fcf9-6b2b-4614-bc4b-b97fca67502d 34 fields · synced Jun 1, 2026