Identity
- Trade Name
- OSSEOTITE NT® EUDAMEDFDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Reusable Surgical Dental Instruments EUDAMEDOSSEOTITE NT® ANGLED OSTEOTOME 6.0 MM FDA UDI
- Model / Reference
- NTOST6A EUDAMEDFDA UDI
- Description
- OSSEOTITE NT® ANGLED OSTEOTOME 6.0 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868012672 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868A1GS EUDAMED
- Direct Marketing DI
- 00844868012672 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L150103 DENTAL OSTEOTOME BLADES, REUSABLE EUDAMED
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental osteotome
Osseotite Nt® by Biomet 3i, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental osteotome.
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- Tatum Surgical-Osteotome — SUNCOAST DENTAL, INC. · Class I
- OSTEOTOME — KLS-Martin L.P. · Class I
- OSTEOTOME REPLACE - 6.0mm - RADIUS HF MARKINGS 7-10-13-16 — W.H. Holden, Inc. · Class I
- KOHDENT — Kohler Medizintechnik 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
- Biomet 3i, Llc
Sources (2)
- FDA UDI 5e539b33-af12-4dac-a27d-8d8484921896 35 fields · synced Jul 9, 2026
- EUDAMED 6397389f-0e2c-48fe-bd2d-ba2d3063b66a 61 fields · synced Jul 9, 2026