MOR Twist Drill, 1.2mm
- Primary DI
- 00841549114755
- Brand
- MOR Twist Drill, 1.2mm
- Company
- STERNGOLD DENTAL LLC
- Model
- 905268
- Device 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.
- Published
- 2016-03-10
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| DZA | Drill, Dental, Intraoral |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 1 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K153173 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549114755 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549114755 | 00841549114755 | 841549114755 | 0841549114755 |
GMDN Terms#
| Term | Definition |
|---|---|
| Fixture/appliance dental drill bit, single-use | A sterile shaft of metal 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. 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. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 401-871-3489 | maria.rao@sterngold.com |
Regulatory Flags#
- DUNS number
- 124763728
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
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| 00841549104008 | ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) | 812544 | 2017-03-22 | |
| 00841549104015 | ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE) | 812545 | 2017-03-22 | |
| 00841549104022 | ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE) | 812546 | 2017-03-22 | |
| 00841549104039 | ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE) | 812547 | 2017-03-22 | |
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