HERO 642
FDA 510(k) clearance K970649 · decided 1997-05-16
Clearance details
- K-number
- K970649
- Device name
- HERO 642
- Applicant
- Micro-Mega
- Decision
- Substantially Equivalent
- Date received
- 1997-02-20
- Decision date
- 1997-05-16
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- EKS
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- France, FR
- 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 |
|---|---|---|
| TF ROTARY NICKEL TITANIUM FILE (K062856) | Ormco Corp. | 2006-12-13 |
| NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES (K004031) | Dental Power, Inc. | 2001-03-28 |
| NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES (K971319) | Tycom Dental | 1997-05-22 |
| QUANTEC SERIES 2000 ENDODONTIC FILES (K962031) | Tycom Dental | 1996-06-04 |
| SHAPING HEDSTROM N.T. (K953604) | Sybron Dental Specialties, Inc. | 1995-09-28 |
| NICKEL-TITANIUM K-TYPE FILE (K935542) | Union Broach, Div. Moyco Industries, Inc. | 1994-01-03 |
| LIGHTSPEED DENTAL HAND INSTRUMENT (K932529) | Lightspeed Endodontics | 1993-11-04 |
| PROFILE SERIES 29 FILES (K933582) | Tulsa Dental Products, Ltd. | 1993-10-20 |
| DENTAURUM CERAMIC DEBONDING UNIT (K902018) | Dentauraum, Inc. | 1991-04-03 |
| SOLID CORE GUTTA PERCHA CARRIER (K905640) | The Hygenic Corp. | 1991-03-05 |
| PROCEDURE KIT/ROUTINE DENTAL PROCEDURES (K905461) | Angiosystems, Inc. | 1991-03-05 |
| VISIONER 21-A (K901037) | J. Morita USA, Inc. | 1990-08-14 |
Recalls involving this device
No recalls on record reference this clearance.