| Primary Device ID | D768T306030 |
| NIH Device Record Key | cbdd4a74-74c0-4501-a0f0-abc967784ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XP1 |
| Version Model Number | T30603 |
| Company DUNS | 787471015 |
| Company Name | KEYSTONE DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(781)328-3313 |
| sshahid@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com | |
| Phone | +1(866)902-9272 |
| info@keystonedental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D768T306030 [Primary] |
| NDP | Accessories, implant, dental, endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-16 |
| Device Publish Date | 2019-05-08 |
| D768G151000 - Genesis ACTIVE | 2023-06-27 Genesis DLC Full Depth Twist Drill Ø2.0 x 8.5-16 mm |
| D768G151010 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 8.5 mm |
| D768G151020 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 10 mm |
| D768G151030 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 11.5 mm |
| D768G151040 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 13 mm |
| D768G151050 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.5 x 16 mm |
| D768G151060 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.8 x 8.5 mm |
| D768G151070 - Genesis ACTIVE | 2023-06-27 Genesis DLC Final Tapered Drill Ø3.8 x 10 mm |