| Primary Device ID | 00850073333518 |
| NIH Device Record Key | 2899de76-d00b-4641-a9a2-8692dc7c4f05 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tapered Drill 4.2X19 - Blue |
| Version Model Number | Dental Drill bit, reusable / Tapered Drill 4.2X19 |
| Company DUNS | 004512027 |
| Company Name | 3D DIAGNOSTIX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850073333518 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
[00850073333518]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-19 |
| Device Publish Date | 2025-09-11 |
| 00850073333563 - 3DDX Straight Drill Kit | 2025-09-29 A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dent |
| 00850073333013 - Night Guard | 2025-09-19 Night Guards are designated to alleviate the pain and damage caused by bruxing or clenching the teeth. Severe tooth, jaw or faci |
| 00850073333136 - Straight Drill LSD 02.75x15 - Black | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |
| 00850073333143 - Straight Drill LSD 02.75x18 - White | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |
| 00850073333150 - Straight Drill LSD 02.75x20 - Blue | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |
| 00850073333167 - Straight Drill LSD 02.75x23 - Green | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |
| 00850073333174 - Straight Drill LSD 02.75x25 - Yellow | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |
| 00850073333198 - Straight Drill LSD 03.15x15 - Black | 2025-09-19 Intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavit |