FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NuSmile NuNamel Pit & Fissure Sealant
DI: 00810118106477
·
Model: NNSPK
·
NUSMILE, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NuSmile NuNamel Pit & Fissure Sealant
- Primary DI
- 00810118106477
- Version / Model
- NNSPK
- Company Name
- NUSMILE, LTD.
- Labeler DUNS
- 185497372
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-24
- Public Version
- 2
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- 66a28812-9f41-4cca-9b79-6e126d3d231b
- Distribution End Date
- 2026-01-13
Device Description
NuNamel Pit & Fissure Sealant 4 x 1.2 ml syringe + 20 tips Professional Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34771 | Dental unfilled resin sealant/coating | A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810118106477 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112517 | 000 |