FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NizLoc Imp Coping
DI: 00810157313348
·
Model: NLIC
·
Paragon Implant Mfg., LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NizLoc Imp Coping
- Primary DI
- 00810157313348
- Version / Model
- NLIC
- Catalog Number
- NLIC
- Company Name
- Paragon Implant Mfg., LLC
- Labeler DUNS
- 118698566
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-08
- Public Version
- 1
- Public Version Date
- 2026-01-16
- Public Version Status
- New
- Public Device Record Key
- 1a405642-4e9a-4393-8ff4-f014cc61a0a0
- Distribution End Date
- 2026-01-15
Device Description
NizLoc Impression Coping (2 pcs)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64323 | Dental implant abutment impression cap | A small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810157313348 | GS1 |
Customer Contacts
- Phone
- 1-855-649-4365
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5.4 | Millimeter | |
| Length | 5.5 | Millimeter |