TOUCH N' HEAT, MODIFICATION
FDA 510(k) clearance K921604 · decided 1992-08-24
Clearance details
- K-number
- K921604
- Device name
- TOUCH N' HEAT, MODIFICATION
- Applicant
- Analytic Technology
- Decision
- Substantially Equivalent
- Date received
- 1992-03-27
- Decision date
- 1992-08-24
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- EKZ
- Device class
- 2
- Regulation number
- 872.4920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| X O ODONTOSURGE 4 (K023672) | Xo Care A/S | 2003-04-29 |
| BONART ART-E1 ELECTROSURGERY UNIT (K020080) | Diagnostic Data, Inc. | 2002-02-19 |
| ODONTOSURGE 3 (K001560) | Odonto-Wave | 2000-08-24 |
| WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (K000768) | Wallach Surgical Devices, Inc. | 2000-04-11 |
| BI-DENT (K982229) | Valley Forge Scientific Corp. | 1998-08-13 |
| ODONTOSURGE 2 (K981390) | Periogiene | 1998-06-11 |
| ARTHROCARE DENTAL ELECTROSURGERY SYSTEM (K962445) | Arthrocare Corp. | 1996-07-30 |
Recalls involving this device
No recalls on record reference this clearance.