Dental Pain Eraser
FDA 510(k) clearance K182947 · decided 2019-03-26
Clearance details
- K-number
- K182947
- Device name
- Dental Pain Eraser
- Applicant
- Synapse Dental, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-10-23
- Decision date
- 2019-03-26
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- LWM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cranston, RI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dental Pain Eraser (K193570) | Synapse Dental | 2020-01-17 |
| Dental Pain Eraser (K192429) | Synapse Dental | 2020-01-14 |
| TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM (K011001) | Satelec | 2001-06-07 |
| 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 (K935304) | 3M Company | 1994-03-16 |
| 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (K935082) | 3M Company | 1994-01-26 |
| 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS (K935085) | 3M Company | 1994-01-26 |
| CEDETA (K915717) | D-W Intl. | 1992-11-23 |
| 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM (K920119) | 3M Company | 1992-05-22 |
| ULTRACALM (K910625) | Sion Technology, Inc. | 1992-05-15 |
| MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) (K900731) | Medical Consultants Intl. , Ltd. | 1990-12-17 |
| COMFORTRON II (TENS) (K902948) | M. D. Products | 1990-12-17 |
| COMFORTRON DENTAL ANESTHESIA APPARATUS (K884586) | M. D. Products | 1989-04-14 |
Recalls involving this device
No recalls on record reference this clearance.