510(k) K970649
- Device
- HERO 642
- Applicant
- MICRO-MEGA
- 510(k) number
- K970649
- Product code
- EKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-16
- Date received
- 1997-02-20
- Regulation
- 872.4565
- Classification name
- File, Pulp Canal, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JM BADOZ
- Address
- 5-12 Rue Du Tunnel 25006 Besancon France FR
FDA Registration Numbers#
- 3007255375
- 3044175603
- 3027344570
- 3038718579
- 2245304
- 3004425647
- 3023443842
- 3043149181
- 3006542438
- 1215305
- 2245654
- 3006531065
- 2081055
- 3017910185
- 3005562917
- 3012322979
- 1836229
- 1054713
- 3043655586
- 3009219448
- 3007284437
- 2416455
- 8010468
- 8010908
- 3015136927
- 9615399
- 3015060193
- 3010160527
- 2437780
- 3013734586
- 3015526995
- 3042158426
- 8030938
- 8010629
- 8043792
- 3026760
- 3019741877
- 2245590
- 3014270297
- 3008346537
- 8023007
- 3012101632
- 3031191035
- 2031093
- 3038187461
- 1836161
- 3002807310
- 3002907620
- 3014326245
- 3030015903
- 3012477813
- 3013372622
- 3034729565
- 3009431661
- 3005663302
- 3008249935
- 3012421607
- 3021388085
- 3030126955
- 3009560600
- 3024787345
- 2086043
- 3004467019
- 9680913
- 3003418325
- 3042866301
- 3006174295
- 3004645512
- 3021343214
- 3006444232
- 8043962
- 3002820615
- 3015276580
- 3009391651
- 2024949
- 2024312
- 3009130085
- 3021971019
- 3017498782
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062856 | TF ROTARY NICKEL TITANIUM FILE | Ormco Corp. | 2006-12-13 |
| K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Dental Power, Inc. | 2001-03-28 |
| K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | Tycom Dental | 1997-05-22 |
| K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental | 1996-06-04 |
| K953604 | SHAPING HEDSTROM N.T. | Sybron Dental Specialties, Inc. | 1995-09-28 |
| K935542 | NICKEL-TITANIUM K-TYPE FILE | Union Broach, Div. Moyco Industries, Inc. | 1994-01-03 |
| K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT | Lightspeed Endodontics | 1993-11-04 |
| K933582 | PROFILE SERIES 29 FILES | Tulsa Dental Products, Ltd. | 1993-10-20 |
| K902018 | DENTAURUM CERAMIC DEBONDING UNIT | Dentauraum, Inc. | 1991-04-03 |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Angiosystems, Inc. | 1991-03-05 |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | The Hygenic Corp. | 1991-03-05 |
| K901037 | VISIONER 21-A | J. Morita USA, Inc. | 1990-08-14 |
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. | 1990-05-31 |
| K883418 | DE-BOND 200 | Scheu-Dental | 1989-10-24 |
| K892861 | DENTAL PIK | U.S. Dentek Corp. | 1989-09-15 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases