FDA UDI
In Commercial Distribution
🇺🇸 United States
Starter Drill
DI: 00810157313881
·
Model: SD1.8
·
Paragon Implant Mfg., LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Starter Drill
- Primary DI
- 00810157313881
- Version / Model
- SD1.8
- Catalog Number
- SD1.8
- Company Name
- Paragon Implant Mfg., LLC
- Labeler DUNS
- 118698566
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-07
- Public Version
- 1
- Public Version Date
- 2026-01-15
- Public Version Status
- New
- Public Device Record Key
- a84fff5a-c259-4a9f-b53b-c86e7c0c1c61
Device Description
1.8mmD Starter Drill with 7mmL Stop
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45714 | Fixture/appliance dental drill bit, reusable | A shaft of metal 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 fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810157313881 | GS1 |
Customer Contacts
- Phone
- 1-855-649-4365
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.8 | Millimeter | |
| Length | 7.0 | Millimeter |