510(k) K897195
- Device
- A-company Electrothermal Debonding Device (etd)
- Applicant
- A COMPANY, INC.
- 510(k) number
- K897195
- Product code
- EKS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-31
- Date received
- 1989-12-29
- Regulation
- 872.4565
- Classification name
- File, Pulp Canal, Endodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID A ENSOR
- Address
- 11436 Sorrento Valley Rd. Post Office Box 81247 San Diego CA US 92138 92138
FDA Registration Numbers#
- 1000286794
- 8030962
- 8043962
- 3023816720
- 8031011
- 3008902714
- 1836161
- 3043149181
- 3026760
- 3006621310
- 9611053
- 8030343
- 1836229
- 3009768364
- 3015526995
- 3023443842
- 3010864832
- 3008370577
- 3021971019
- 3030126955
- 3005562917
- 3008590661
- 2086043
- 3009171220
- 3038718579
- 3009756327
- 3006550196
- 3004580125
- 3017953780
- 3034729565
- 3015276158
- 3002692886
- 3021284315
- 3030015903
- 8031010
- 8030637
- 3004467019
- 9615399
- 1215305
- 3007255375
- 3017498782
- 2032098
- 2320721
- 8010516
- 3027343382
- 3008346537
- 3010583458
- 1054713
- 1047843
- 3007284437
- 3003444492
- 2024949
- 3012101632
- 3005628474
- 3006017180
- 9616128
- 9680913
- 9681254
- 3014270297
- 3002820615
- 3016875543
- 3010656982
- 3014334038
- 3044175603
- 3003487388
- 3003882387
- 3009219448
- 3008352964
- 3012354669
- 3014326245
- 3009391651
- 3002907620
- 3027344570
- 3038187461
- 3008249935
- 3043655586
- 3005831677
- 3004645512
- 8030938
- 1032227
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 |
| K970649 | HERO 642 | Micro-Mega | 1997-05-16 |
| 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 |
| K883418 | DE-BOND 200 | Scheu-Dental | 1989-10-24 |
| K892861 | DENTAL PIK | U.S. Dentek Corp. | 1989-09-15 |