510(k) K953604
- Device
- SHAPING HEDSTROM N.T.
- Applicant
- SYBRON DENTAL SPECIALTIES, INC.
- 510(k) number
- K953604
- Product code
- EKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-09-28
- Date received
- 1995-08-02
- Regulation
- 872.4565
- Classification name
- File, Pulp Canal, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEFFREY A ANDERSON
- Address
- 1332 S. Lone Hill Ave. Glendora CA US 91740 91740
FDA Registration Numbers#
- 3014334038
- 3007301326
- 3042866301
- 9611053
- 3021388085
- 3012421607
- 3021284315
- 8030938
- 9616128
- 2032098
- 3010145273
- 3042283835
- 3005663302
- 3015276158
- 3009431661
- 3021023132
- 3012101632
- 3009171220
- 1000286794
- 3021343214
- 3003882387
- 3024787345
- 3016875543
- 3027520354
- 3014683120
- 3003418325
- 3007255375
- 3010583458
- 3006444232
- 9615399
- 3013538161
- 3012628066
- 3015136927
- 3044819802
- 3023816720
- 3012322979
- 2437780
- 3009756327
- 3045855232
- 3013734586
- 9614726
- 3009655316
- 3008887731
- 1054713
- 3031191035
- 8023007
- 3008249935
- 3030015903
- 3006621310
- 2245304
- 1319660
- 2024949
- 3013372622
- 2031093
- 3026760
- 3007284437
- 3009560600
- 8030962
- 3014953747
- 3044175603
- 3042158426
- 3034729565
- 3004580125
- 3019567808
- 3015526995
- 3015060193
- 3008370577
- 3002807310
- 8010629
- 8043962
- 1032227
- 3006542438
- 3009732568
- 3015276580
- 3006531065
- 3027344570
- 2245654
- 3004046477
- 3004467019
Source Documents#
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 |
| K970649 | HERO 642 | Micro-Mega | 1997-05-16 |
| K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental | 1996-06-04 |
| 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