Identity
- Trade Name
- Surgical Guide FDA UDI
- Generic Name
- Dental implantation drilling template, custom-made FDA UDI
- Device Name
- Surgical Guide is intended to be used as an aid in the surgical placement of endosseous dental implants. Surgical guide allows a dental surgeon to place an implant in a very specific, pre-planned location to give the most ideal depth, angulation, and size of implant to fit the space. FDA UDI
- Model / Reference
- Dental Implantation Drilling Template-Custom Made Surgical Guide FDA UDI
- Description
- Surgical Guide is intended to be used as an aid in the surgical placement of endosseous dental implants. Surgical guide allows a dental surgeon to place an implant in a very specific, pre-planned location to give the most ideal depth, angulation, and size of implant to fit the space. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850073333020 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implantation drilling template, custom-made FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental implantation drilling template, custom-made
Surgical Guide by 3d Diagnostix, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implantation drilling template, custom-made.
- MGUIDE® — DENTSPLY IH, INC. · Class I
- Coredent Surgical Guide — Coredent · Class I
- MGUIDE® — DENTSPLY IH, INC. · Class I
- MGUIDE® — DENTSPLY IH, INC. · Class I
- Smart Template Free-end Bridge Large, Short — OSSTEM IMPLANT Co., Ltd. · Class I
- MGUIDE® — DENTSPLY IH, INC. · Class I
- Smart Template2-unit Bridge Small, Short — OSSTEM IMPLANT Co., Ltd. · Class I
- MGUIDE® — DENTSPLY IH, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Manufacturer
- 3d Diagnostix, Inc.
Sources (1)
- FDA UDI 46d6efce-688f-4a3e-a277-575278703677 33 fields · synced Jun 1, 2026