SVENSK TK/2
FDA 510(k) clearance K820503 · decided 1982-03-19
Clearance details
- K-number
- K820503
- Device name
- SVENSK TK/2
- Applicant
- Peter Martin Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-25
- Decision date
- 1982-03-19
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- JEQ
- Device class
- 1
- Regulation number
- 872.6865
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| SONICARE ADVANCE TOOTHBRUSH, MODEL 4900 (K040416) | Philips Oral Healthcare, Inc. | 2004-07-02 |
| BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES (K022900) | John O. Butler Co. | 2002-11-14 |
| SONICWAVE SONIC PLAQUE REMOVER (K012914) | Homedics, Inc. | 2001-10-01 |
| POWERED TOOTHBRUSH (K970381) | Emjoi Action USA, Ltd. | 1997-04-18 |
| TRAV-LER KIT (K943942) | John O. Butler Co. | 1995-03-08 |
| HUKUBA HYG ELECTRIC IONIC TOOTHBRUSH (K945248) | Hukuba Dental Corp. | 1995-01-26 |
| JENERIC/PENTRON P0WERED TOOTHBRUST (K944084) | Jeneric/Pentron, Inc. | 1994-12-20 |
| PEMBUSH (K942634) | Crossroads Trading Co. | 1994-09-02 |
Recalls involving this device
No recalls on record reference this clearance.