FDA UDI In Commercial Distribution 🇺🇸 United States

Straight Drill LSD 03.15x23 - Green

DI: 00850073333228 · Model: Dental drill bit, reusable / Straight Drill LSD 03.15x23 - Green · 3D DIAGNOSTIX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Straight Drill LSD 03.15x23 - Green
Primary DI
00850073333228
Version / Model
Dental drill bit, reusable / Straight Drill LSD 03.15x23 - Green
Company Name
3D DIAGNOSTIX, INC.
Labeler DUNS
004512027
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-11
Public Version
1
Public Version Date
2025-09-19
Public Version Status
New
Public Device Record Key
52ca550d-4b28-4f89-81d7-660339af6c62

Device Description

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 appliance.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Dry Heat Sterilization

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
45714 Fixture/appliance dental drill bit, reusable

Identifiers

Type ID
Primary 00850073333228