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
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- DAVID A ENSOR
- Address
- 11436 Sorrento Valley Rd. Post Office Box 81247 San Diego CA US 92138 92138
FDA Registration Numbers
- 3034729565
- 8030938
- 8030962
- 1032227
- 3009431661
- 3012627824
- 3006621310
- 3007791573
- 1054713
- 3004569445
- 3013734586
- 3023816720
- 3043149181
- 3002820615
- 1215305
- 3014326245
- 2032098
- 8020994
- 3030015903
- 8023007
- 9614726
- 3010145273
- 3015548849
- 2031093
- 3004645512
- 3026760
- 3007301326
- 3007255375
- 3031191035
- 3011554142
- 1319660
- 3011713204
- 3017498782
- 2437780
- 3005663302
- 3006531065
- 3010864832
- 3009756327
- 3003487388
- 2245654
- 3009171220
- 2081055
- 3009560600
- 3013372622
- 3021023132
- 3006174295
- 3012477813
- 8030637
- 3015060193
- 3043648115
- 3010817521
- 3021971019
- 3027343382
- 3008249935
- 3007284437
- 3002907620
- 3012421607
- 3005562917
- 3009391651
- 3006542438
- 3002807310
- 3030378557
- 2320721
- 3003882387
- 3021388085
- 3038187461
- 3012322979
- 8031010
- 1000286794
- 3015276158
- 3006186796
- 3009732568
- 3004467019
- 1526534
- 3042283835
- 3009219448
- 3005628474
- 3008370577
- 8010908
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
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 |