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2.5mm-3.5mm ZGO Densah Bur 55mm length
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref ZT2535-55Model Zygoma Densah Burs
by Versah, Llc
Identity
- Trade Name
- Zygoma Densah Bur EUDAMED2.5mm-3.5mm ZGO Densah Bur 55mm length FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid implants). FDA UDI
- Model / Reference
- ZT2535-55 EUDAMEDFDA UDIZygoma Densah Burs EUDAMED
- Description
- ZGO Densah Burs are indicated for use to prepare osteotomies for implant placement in maxilla (including the zygoma and ptergoid implants). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017652668 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017652DensahZ85 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L150101 ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic bur, reusable
2.5mm-3.5mm ZGO Densah Bur 55mm length by Versah, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic bur, reusable.
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- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Versah, Llc
Sources (2)
- FDA UDI abdbbe2a-e41c-4673-964b-55094d5ddcc5 34 fields · synced Oct 7, 2026
- EUDAMED 1cee4c0b-127d-4cc8-acea-d2f5975940d4 61 fields · synced Oct 7, 2026