FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DenTASTIC® - Refill Kit
DI: D701DASC12
·
Model: DASC1
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DenTASTIC® - Refill Kit
- Primary DI
- D701DASC12
- Version / Model
- DASC1
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-21
- Public Version
- 5
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- e95a1469-9152-4ca1-8c87-a0bf8136b6aa
- Distribution End Date
- 2020-01-01
Device Description
6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C 6 ML EACH UNFILLED RESIN BONDING AGENT PARTS 1 AND 2 5 ML ETCH ALL, 10% PHOSPHORIC ACID ETCH GEL
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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set | A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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 | D701DASC12 | HIBCC |