Primary Device ID | 00850073333365 |
NIH Device Record Key | c3f526cc-a9a3-43a5-8423-2d91370f3088 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Straight Drill LSD 04.20x27 - Red |
Version Model Number | Dental drill bit, reusable / Straight Drill LSD 04 |
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 | 00850073333365 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
Dry Heat Sterilization
[00850073333365]
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 |