MARK3
- Primary DI
- D79659701
- Brand
- MARK3
- Company
- CARGUS INTERNATIONAL, INC
- Model
- 5970
- Device description
- Endo Pulp Vitality Refrigerant Spray 6oz. Bottle - MARK3®
- Published
- 2021-10-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EAT | Tester, Pulp | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D79659701 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Cryogenic spray, dental | A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused. |
Regulatory Flags
- DUNS number
- 096191093
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 10840016202053 | CanalPro | COLTENE/WHALEDENT INC | EAT | 2026-02-10 |
| 00850080491034 | Primo Dental Products | ECOTEC MANUFACTURING, INC. | EAT | 2025-11-26 |
| 00850080491010 | Marie Reiko | ECOTEC MANUFACTURING, INC. | EAT | 2025-10-13 |
| 00860177000698 | Allure Ortho | ECOTEC MANUFACTURING, INC. | EAT | 2025-07-29 |
| 00817744022720 | Primo Freeze | ECOTEC MANUFACTURING, INC. | EAT | 2024-10-02 |
| 00752080000035 | SkyChoice Polar-Freeze | ECOTEC MANUFACTURING, INC. | EAT | 2024-09-25 |
| 00752080000028 | Hexa Freeze | ECOTEC MANUFACTURING, INC. | EAT | 2024-09-24 |
| 00752080000011 | RMH3 Dental | ECOTEC MANUFACTURING, INC. | EAT | 2024-08-19 |
| 00810132807435 | HOUSE BRAND DENTISTRY | ECOTEC MANUFACTURING, INC. | EAT | 2024-03-18 |
| D771412051 | WINTERGREEN FREEZE SPRAY | ECOTEC MANUFACTURING, INC. | EAT | 2023-10-31 |
| 00889813059845 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | EAT | 2023-05-25 |
| 10371347008125 | Advance Dental Products | The Atlanta Dental Supply Company | EAT | 2022-12-07 |
| D773330100050 | Health-Tec/DHP Refrigerant Spray | Dental Health Products Inc | EAT | 2022-10-20 |
| 06970873260013 | PULP TESTER | DENJOY DENTAL CO.,LTD | EAT | 2022-02-19 |
| 00810000520077 | Gentle Pulse™ | PARKELL, INC. | EAT | 2021-12-10 |
| 00810000520657 | Digitest™ | PARKELL, INC. | EAT | 2021-12-10 |
| 00810000520961 | Gentle Pulse™ | PARKELL, INC. | EAT | 2021-12-10 |
| 00810000520978 | Gentle Pulse™ | PARKELL, INC. | EAT | 2021-12-10 |
| 00195062030086 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011122 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011139 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011146 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011153 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030130 | Touch 'n Heat | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030970 | Lead Cord | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030987 | File Clip | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031021 | Elements | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031038 | Satellite with Satellite Cord | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031045 | Elements | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030963 | Lip Hook | Kerr Corporation | EAT | 2021-03-05 |