Identity
- Trade Name
- Immediate Molar Indicator EUDAMEDImmediate Molar FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Non-Sterile Manual Dental Instruments EUDAMEDImmediate Molar Depth Indicator 9mmD, 8-11.5mmL FDA UDI
- Model / Reference
- IMDI9 EUDAMEDFDA UDI
- Description
- Immediate Molar Depth Indicator 9mmD, 8-11.5mmL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868048497 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868A2GU EUDAMED
- Direct Marketing DI
- 00844868048497 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
Category: Dental implantation depth/angle gauge, reusable
Immediate Molar by Biomet 3i, Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
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 02d3885d-67e9-4f90-9a8a-7fb18f7a7b7b 34 fields · synced Oct 8, 2026
- EUDAMED 2113389b-2143-4cf0-8fca-64f2da9fb35f 61 fields · synced Oct 7, 2026