ELECTRO FLOSS
FDA 510(k) clearance K930178 · decided 1993-07-28
Clearance details
- K-number
- K930178
- Device name
- ELECTRO FLOSS
- Applicant
- Arizona Implant Dentistry
- Decision
- Substantially Equivalent
- Date received
- 1993-01-13
- Decision date
- 1993-07-28
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- JET
- Device class
- 1
- Regulation number
- 872.6650
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Tempe, AR, 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 |
|---|---|---|
| REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC. (K963747) | Whitehill Manufacturing, Inc. | 1996-12-16 |
| ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE (K942633) | Oral-B Laboratories | 1995-04-27 |
| GUM MASSAGER (K911418) | Burn-Henderson Partnership | 1991-07-17 |
| MASSAGING PICK FOR ORAL HYGIENE (K885189) | Dentek Corp. | 1989-03-17 |
| PLAKOF (K890910) | Ximex, Ltd. | 1989-03-16 |
| FLOSSIE (K883225) | Richard G. Deniro | 1988-08-30 |
| PERMA-PIC PLASTIC TOOTHPICK (K881900) | The Perma-Pic Co. | 1988-06-01 |
| SUPER PIK MASSAGING PICK FOR ORAL HYGIENE (K881046) | U.S. Dentek Corp. | 1988-05-13 |
| ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (K860779) | William J. Forni, D.D.S. | 1986-04-02 |
| DENTAL MASSAGING PICKS (K850775) | L.A.K. Ent., Inc. | 1985-04-10 |
| ORAPIK PERIODONTAL SCALER (K844238) | Dental Concepts, LLC | 1984-12-03 |
| SANODENT DOUBLE-ENDED INTERDENTAL CLEAN (K832949) | Coopercare, Inc. | 1983-10-04 |
Recalls involving this device
No recalls on record reference this clearance.