ProLube
- Primary DI
- D716PROLUBE51
- Brand
- ProLube
- Company
- TULSA DENTAL PRODUCTS LLC
- Model
- PROLUBE5
- Catalog number
- PROLUBE5
- Device description
- Prolube: 5 count package
- Published
- 2022-09-01
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| EIC | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EIC | Syringe, Periodontic, Endodontic, Irrigating | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D716PROLUBE51 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Dental root surface conditioner | A dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 942778564
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D716PUENDO11 | ProUltra | PUENDO1 | PUENDO1 | 2016-10-07 |
| D716PUENDO151 | ProUltra | PUENDO1-5 | PUENDO1-5 | 2016-11-11 |
| D716PUENDO21 | ProUltra | PUENDO2 | PUENDO2 | 2016-10-07 |
| D716PUENDO31 | ProUltra | PUENDO3 | PUENDO3 | 2016-10-07 |
| D716PUENDO41 | ProUltra | PUENDO4 | PUENDO4 | 2016-10-07 |
| D716PUENDO51 | ProUltra | PUENDO5 | PUENDO5 | 2016-10-07 |
| D716PUENDO61 | ProUltra | PUENDO6 | PUENDO6 | 2016-10-07 |
| D716PUENDO681 | ProUltra | PUENDO6-8 | PUENDO6-8 | 2016-11-11 |
| D716PUENDO71 | ProUltra | PUENDO7 | PUENDO7 | 2016-10-07 |
| D716PUENDO81 | ProUltra | PUENDO8 | PUENDO8 | 2016-10-07 |
| D716PUSINE11 | ProUltra | PUSINE1 | PUSINE1 | 2016-10-07 |
| D716PUSINE161 | ProUltra SINE | PUSINE1-6 | PUSINE1-6 | 2016-11-11 |
| D716PUSINE21 | ProUltra | PUSINE2 | PUSINE2 | 2016-10-07 |
| D716PUSINE31 | ProUltra SINE | PUSINE3 | PUSINE3 | 2016-10-07 |
| D716PUSINE41 | ProUltra SINE | PUSINE4 | PUSINE4 | 2016-10-07 |
| D716PUSINE51 | ProUltra SINE | PUSINE5 | PUSINE5 | 2016-10-07 |
| D716PUSINE61 | ProUltra SINE | PUSINE6 | PUSINE6 | 2016-10-07 |
| D716PUSURG11 | ProUltra | PUSURG1 | PUSURG1 | 2016-10-07 |
| D716PUSURG161 | ProUltra | PUSURG1-6 | PUSURG1-6 | 2016-11-11 |
| D716PUSURG21 | ProUltra | PUSURG2 | PUSURG2 | 2016-10-07 |
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