DENTO-SURGE
FDA 510(k) clearance K955176 · decided 1996-04-15
Clearance details
- K-number
- K955176
- Device name
- DENTO-SURGE
- Applicant
- Ellman Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-13
- Decision date
- 1996-04-15
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- EKZ
- Device class
- 2
- Regulation number
- 872.4920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Sound Beach, NY, 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 |
|---|---|---|
| Root ZX3 (K213477) | J. Morita USA, Inc. | 2022-08-03 |
| PERFECT TISSUE CONTOURING SYSTEM II (K071632) | Coltene/Whaledent, Inc. | 2007-10-18 |
| THE FUGO BLADE FOR DENTISTRY (K063468) | Medisurg , Ltd. | 2007-04-18 |
| MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT (K052622) | Macan Engineering Co. | 2005-12-09 |
| MC6A (K050735) | Macan Engineering Co. | 2005-05-23 |
| 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.