TEMPCANAL™
- Primary DI
- D701PTCK2
- Brand
- TEMPCANAL™
- Company
- PULPDENT CORPORATION
- Model
- PTCK
- Device description
- KIT: 3 mL syringe + 12 needles (22 & 25 gauge) - Calcium hydroxide canal treatment paste, radiopaque
- Published
- 2016-09-08
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Product Codes
| Code | Name |
|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D701PTCK2 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Calcium hydroxide dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 001006089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- 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
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|---|---|---|---|---|
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| D701T20G191 | Applicator Tips | T20G19 | 2024-12-03 | |
| D701SVBFUS2 | ACTIVA™ BioACTIVE Bulk Flow | S-VBFUS | 2024-12-02 | |
| D701SVKBFUS2 | ACTIVA™ Kids BioACTIVE Bulk Flow | S-VKBFUS | 2024-12-02 | |
| D701VBF1US2 | ACTIVA™ BioACTIVE Bulk Flow | VBF1US | 2024-12-02 | |
| D701VKBF1OW2 | ACTIVA™ Kids BioACTIVE Bulk Flow | VKBF1OW | 2024-12-02 | |
| D710VKBF1US2 | ACTIVA™ Kids BioACTIVE Bulk Flow | VKBF1US | 2024-12-02 | |
| D701SUNO2 | DENTASTIC UNO SAMPLE | SUNO | 2018-08-10 | |
| D701SVPFA32 | Activa Presto | S-VPFA3 | 2023-06-22 | |
| D701SVPFA352 | Activa Presto | S-VPFA35 | 2023-06-22 | |
| D701SVPFA42 | Activa Presto | S-VPFA4 | 2023-06-22 | |
| D701SVPFA62 | Activa Presto | S-VPFA6 | 2023-06-22 | |
| D701SVPFB12 | Activa Presto | S-VPFB1 | 2023-06-22 | |
| D701TTP502 | Tuff Temp Plus Provisional Veneer, Crown, and Bridge Resin | TTP50 | 2018-12-14 | |
| D701TTP50A12 | TUFF-TEMP PLUS | TTP50A1 | 2019-11-22 | |
| D701TTP50A1X2 | TUFF-TEMP PLUS | TTP50A1X | 2019-11-22 | |
| D701TTP50A22 | TUFF-TEMP PLUS | TTP50A2 | 2019-11-22 | |
| D701TTP50A2X2 | TUFF-TEMP PLUS | TTP50A2X | 2019-11-22 | |
| D701TTP50A32 | TUFF-TEMP PLUS | TTP50A3 | 2019-11-22 |
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| D161250020 | AxioPro ART | Axiodent Inc. | EJK | 2024-10-04 |
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| D161250050 | AxioCAL LC | Axiodent Inc. | EJK | 2024-10-04 |
| D161250060 | AxioCAL LC | Axiodent Inc. | EJK | 2024-10-04 |
| D161250080 | AxioCAL | Axiodent Inc. | EJK | 2024-10-04 |
| D161250090 | AxioCAL | Axiodent Inc. | EJK | 2024-10-04 |
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| D161250110 | AxioCAL | Axiodent Inc. | EJK | 2024-10-04 |
| D161250150 | AxioCAL SC | Axiodent Inc. | EJK | 2024-10-04 |
| D161250160 | AxioCAL SC | Axiodent Inc. | EJK | 2024-10-04 |
| D161250170 | AxioCAL LC | Axiodent Inc. | EJK | 2024-10-04 |
| D161250180 | AxioPro ART | Axiodent Inc. | EJK | 2024-10-04 |
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| D956APEXBIO0 | ApexPaste Bio | D.S.I DENTAL SOLUTIONS LTD | EJK | 2023-02-15 |
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