STERILE SUREFLEX FILES AND INSTRUMENTS
FDA 510(k) clearance K971603 · decided 1997-06-04
Clearance details
- K-number
- K971603
- Device name
- STERILE SUREFLEX FILES AND INSTRUMENTS
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-01
- Decision date
- 1997-06-04
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- EFA
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Dental Handpiece (K192809) | Micro-Nx Co., Ltd. | 2020-08-25 |
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| MASTERmatic LUX (K143465) | Kaltenbach & Voigt GmbH | 2015-04-09 |
| RDT3 HANDPIECE HEAD MODEL RDT3 (K101172) | Redent Nova, Ltd. | 2010-07-27 |
| ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE (K093894) | Anthogyr | 2010-03-03 |
| INTRA LUX HEAD 3 LDSY (K092446) | Kaltenbach & Voigt GmbH & Co. | 2009-11-03 |
| LOW & HIGH SPEED KIT (K090055) | Dpm USA Corp. | 2009-10-27 |
| STRONG IMPLANT HANDPIECES (K092412) | Saeshin Precision Co., Ltd. | 2009-09-03 |
| MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES (K090676) | Anthogyr | 2009-05-22 |
| MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL (K070084) | Est. Anthogyr | 2007-03-08 |
| HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H) (K061701) | J. Morita USA, Inc. | 2006-08-25 |
| EXCEL HIGH SPEED DENTAL HANDPIECE (K061581) | Orthosource, Inc. | 2006-08-16 |
Recalls involving this device
No recalls on record reference this clearance.