Identity
- Trade Name
- MOR Twist Drill, 1.2mm FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- A sterile shaft of metal (a drill bit) intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is typically made of a highgrade stainless steel alloy. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single use device that is intended, in terms of sterility, for a single patient use. FDA UDI
- Model / Reference
- 905268 FDA UDI
- Description
- A sterile shaft of metal (a drill bit) intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is typically made of a highgrade stainless steel alloy. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single use device that is intended, in terms of sterility, for a single patient use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841549114755 FDA UDI
- 510(k) Number
- K153173 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixture/appliance dental drill bit, single-use
MOR Twist Drill, 1.2mm by Sterngold Dental LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, single-use.
- IQ Dental — IQ DENTAL SUPPLY LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
- Trefoil™ — Nobel Biocare AG · Class I
- ELEMENT profile drill — Thommen Medical AG · Class I
- Gates Glidden Drills — TULSA DENTAL PRODUCTS LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
Cleared under the same submission
K153173 also covers:
- MOR Implant 2.1 x 10mm, Ti — Sterngold Dental LLC
- MOR Implant 2.1 x 13mm, Ti — Sterngold Dental LLC
- MOR Implant 2.1 x 15mm, Ti — Sterngold Dental LLC
- MOR Implant 2.4 x 10mm , Ti — Sterngold Dental LLC
- MOR Implant 2.4 x 13mm, Ti — Sterngold Dental LLC
- MOR Implant 2.4 x 15mm, Ti — Sterngold Dental LLC
- MOR® RC-1 — Sterngold Dental LLC
- MOR® RC-1 10 pack — Sterngold Dental LLC
- MOR® RC-2 — Sterngold Dental LLC
- MOR® RC-2 10 pack — Sterngold Dental LLC
- MOR® Temporization Cap — Sterngold Dental LLC
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
- Sterngold Dental LLC
Sources (1)
- FDA UDI 957b4df4-0797-420a-bdeb-a05e628cd8ac 35 fields · synced Jun 1, 2026