FDA UDI
In Commercial Distribution
🇺🇸 United States
EMBRACE WETBOND SEAL-N-SHINE
DI: D701EMSNS2
·
Model: EMSNS
·
PULPDENT CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EMBRACE WETBOND SEAL-N-SHINE
- Primary DI
- D701EMSNS2
- Version / Model
- EMSNS
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-28
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 30f67a3a-a582-4e78-9191-0d9ff2894695
Device Description
6 mL bottle, clear shade, brush handle, 100 brush tips Penetrating Finish and Polishing Resin, Light Cure
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 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 | D701EMSNS2 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020432 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 6 | Milliliter |