ERA® Micro DO Small Post Countersink Bur
- Primary DI
- 00841549102080
- Brand
- ERA® Micro DO Small Post Countersink Bur
- Company
- STERNGOLD DENTAL LLC
- Model
- 811453
- Device description
- A metal device 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. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into. Preparation of the bony receptor site involves the sequential use of drills and drilling components. Sterngold Implamed offers two drilling configurations; Externally Cooled Twist Drills and Internally Cooled Spade Drills. Both styles are precision machined from high strength stainless steel and feature convenient depth markings and standard latch-type connectors.
- Published
- 2020-07-06
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| DZE | Implant, Endosseous, Root-Form |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K902158 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00841549102080 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00841549102080 | 00841549102080 | 841549102080 | 0841549102080 |
GMDN Terms#
| Term | Definition |
|---|---|
| Fixture/appliance dental drill bit, reusable | A 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 manual or power tool handpiece that provides rotation. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| 5082265660 | laura.greige@sterngold.com |
Regulatory Flags#
- DUNS number
- 124763728
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00841549118517 | SternTek Duplicating Material | 222012 | 2023-10-04 | |
| 00841549101823 | ERA® DO LP Basic Kit w/ Tools SS | 811412 | 2020-07-07 | |
| 00841549115042 | Sterngold Implant System Cortical Bone Drill 3.2mm | 905522 | 2020-07-07 | |
| 00841549103841 | ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) | 812435 | 2017-03-21 | |
| 00841549103889 | ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) | 812532 | 2017-03-21 | |
| 00841549103896 | ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD) | 812533 | 2017-03-21 | |
| 00841549103902 | ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD) | 812534 | 2017-03-21 | |
| 00841549103919 | ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) | 812535 | 2017-03-21 | |
| 00841549103926 | ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD) | 812536 | 2017-03-21 | |
| 00841549103933 | ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD) | 812537 | 2017-03-21 | |
| 00841549103940 | ERA® Implant Abutment Micro 0°, 2mm Cuff (BD) | 812538 | 2017-03-21 | |
| 00841549103957 | ERA® Implant Abutment Micro 0°, 3mm Cuff (BD) | 812539 | 2017-03-21 | |
| 00841549103964 | ERA® Implant Abutment Micro 0°, 4mm Cuff (BD) | 812540 | 2017-03-21 | |
| 00841549103988 | ERA® Implant Abutment Micro 0°, 6mm Cuff (BD) | 812542 | 2017-03-22 | |
| 00841549103995 | ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE) | 812543 | 2017-03-22 | |
| 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 | |
| 00841549104046 | ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE) | 812548 | 2017-03-22 |
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