Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental implantation depth/angle gauge, reusable FDA UDI
- Device Name
- Devices for aid dental procedures EUDAMEDDIRECTION INDICATOR FDA UDI
- Model / Reference
- 128.019 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- DIRECTION INDICATOR FDA UDI
Identifiers
- Catalog Number
- 128.019 FDA UDI
- Primary DI / UDI-DI
- 07899878010975 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800053VL EUDAMED
- FDA Product Code
- DZN 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
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDIOuter Diameter — 2.8 Millimeter FDA UDI
Category: Dental implantation depth/angle gauge, reusable
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — 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.
- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Tatum Post Guide 30° — SUNCOAST DENTAL, INC. · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- Glidewell HT™ — PRISMATIK DENTALCRAFT, INC. · Class I
- Parallel Pin — OSSTEM IMPLANT Co., Ltd. · Class I
- Tatum Socket Guide 4.5mm — SUNCOAST DENTAL, INC. · Class I
- KOHDENT — Kohler Medizintechnik GmbH & Co. KG · Class I
- Neoss Implant System — Neoss, Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (2)
- FDA UDI 5858ec4a-ccdb-43ce-80d3-a05d2dbcdd82 37 fields · synced Oct 9, 2026
- EUDAMED 7b7c0ca6-1887-42a7-97e4-8b4075da89b0 61 fields · synced Jun 19, 2026