Identity
- Trade Name
- CERTAIN® EUDAMEDFDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Non-Sterile Manual Dental Instruments EUDAMEDCERTAIN® MICROMINI DIRECTION INDICATOR 10MM(L) FDA UDI
- Model / Reference
- IDIM01 EUDAMEDFDA UDI
- Description
- CERTAIN® MICROMINI DIRECTION INDICATOR 10MM(L) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868004509 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868A2GU EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implantation depth/angle gauge, reusable 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Certain® by Biomet 3i, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implantation depth/angle gauge, reusable.
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- Parallel Pin — OSSTEM IMPLANT Co., Ltd. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Tatum Socket Guide 4.5mm — SUNCOAST DENTAL, INC. · 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 9f2cf081-fd52-4cde-84ad-98cd114a89d1 35 fields · synced Jul 24, 2026
- EUDAMED ef10e3de-0033-4016-bf7e-1bbc4c7b5364 61 fields · synced Jul 24, 2026