FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ProTech SuperBond
DI: D814SBT111
·
Model: SBT11
·
PROTECH PROFESSIONAL PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProTech SuperBond
- Primary DI
- D814SBT111
- Version / Model
- SBT11
- Catalog Number
- SBT11
- Company Name
- PROTECH PROFESSIONAL PRODUCTS INC
- Labeler DUNS
- 117374900
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 5
- Public Version Date
- 2019-05-20
- Public Version Status
- Update
- Public Device Record Key
- 472ab943-df18-4173-b401-3117ae5b686d
- Distribution End Date
- 2016-08-29
Device Description
60 ml ProTech Thinner
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34769 | Denture reliner, elastic, short-term | A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. 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 | D814SBT111 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151646 | 000 |