Prima
- Primary DI
- D76815068K0
- Brand
- Prima
- Company
- KEYSTONE DENTAL, INC.
- Model
- 15068K
- Device description
- Osteotome
- Published
- 2019-05-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| KDG | CHISEL (OSTEOTOME) |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| KDG | Chisel (Osteotome) | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D76815068K0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental osteotome | A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device. |
Regulatory Flags
- DUNS number
- 787471015
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| B382SD914459320 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-25 |
| B382SD914031000 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-20 |
| B382SD914031010 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-20 |
| B382SD914456290 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD9144663010 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD9144663020 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD9144663030 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD9144663040 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD914591000 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| B382SD921648100 | Surgical Direct | Surgical Direct, Inc. | KDG | 2026-02-09 |
| 00810158218635 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2026-01-20 |
| 00810158218734 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2026-01-20 |
| 00810158218499 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2026-01-15 |
| 00810158218536 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2026-01-15 |
| B382SD48820520 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-12-02 |
| 00810158218086 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-11-24 |
| 00810158217393 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-09-29 |
| B382SD9219563010 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-09-22 |
| B382SD936682100 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-09-18 |
| B382SD9146891000 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-09-12 |
| 00810158216471 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-21 |
| 00810158215894 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| 00810158216044 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| 00810158216051 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| 00810158216068 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| 00810158216075 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| 00810158216082 | PRINCETON | Princeton Medical Group, Inc. | KDG | 2025-08-18 |
| B382SD921381020 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-08-11 |
| B382SD921646030 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-08-11 |
| B382SD921646040 | Surgical Direct | Surgical Direct, Inc. | KDG | 2025-08-11 |
keystonedental.com