FDA Product Code
FDA Product Code EKS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4565
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K062856 | TF ROTARY NICKEL TITANIUM FILE | Ormco Corp. | 2006-12-13 | Traditional | PDF ↗ |
| K004031 | NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES | Dental Power, Inc. | 2001-03-28 | Traditional | PDF ↗ |
| K971319 | NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES | Tycom Dental | 1997-05-22 | Traditional | PDF ↗ |
| K970649 | HERO 642 | Micro-Mega | 1997-05-16 | Traditional | PDF ↗ |
| K962031 | QUANTEC SERIES 2000 ENDODONTIC FILES | Tycom Dental | 1996-06-04 | Traditional | PDF ↗ |
| K953604 | SHAPING HEDSTROM N.T. | Sybron Dental Specialties, Inc. | 1995-09-28 | Traditional | PDF ↗ |
| K935542 | NICKEL-TITANIUM K-TYPE FILE | Union Broach, Div. Moyco Industries, Inc. | 1994-01-03 | Traditional | PDF ↗ |
| K932529 | LIGHTSPEED DENTAL HAND INSTRUMENT | Lightspeed Endodontics | 1993-11-04 | Traditional | PDF ↗ |
| K933582 | PROFILE SERIES 29 FILES | Tulsa Dental Products, Ltd. | 1993-10-20 | Traditional | PDF ↗ |
| K902018 | DENTAURUM CERAMIC DEBONDING UNIT | Dentauraum, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | The Hygenic Corp. | 1991-03-05 | Traditional | PDF ↗ |
| K905461 | PROCEDURE KIT/ROUTINE DENTAL PROCEDURES | Angiosystems, Inc. | 1991-03-05 | Traditional | PDF ↗ |
| K901037 | VISIONER 21-A | J. Morita USA, Inc. | 1990-08-14 | Traditional | PDF ↗ |
| K897195 | A-COMPANY ELECTROTHERMAL DEBONDING DEVICE (ETD) | A Company, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K883418 | DE-BOND 200 | Scheu-Dental | 1989-10-24 | Traditional | PDF ↗ |
| K892861 | DENTAL PIK | U.S. Dentek Corp. | 1989-09-15 | Traditional | PDF ↗ |
| K892894 | S-FILE, S-FINDER, S-ENGINE FILE | Svenska Dental Instruments AB | 1989-05-24 | Traditional | PDF ↗ |
| K873671 | COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM | Coltene, Inc. | 1987-10-27 | Traditional | PDF ↗ |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Endo Technic Corp. | 1987-02-27 | Traditional | PDF ↗ |
| K864922 | DENTAL HANDPIECES AND ATTACHMENT | E&D Dental Manufacturing Co. | 1987-02-19 | Traditional | PDF ↗ |
| K870177 | ENDOBRUSH | C & S Microinstruments , Ltd. | 1987-02-19 | Traditional | PDF ↗ |
| K855136 | FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE | Union Broach, Div. Moyco Industries, Inc. | 1986-03-06 | Traditional | PDF ↗ |
| K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | United Dental Mfg., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823684 | FILE TYPE K ENDODONTIC | United Dental Mfg., Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823316 | DENTAL INSTRUMENTS - FILES | Miltex, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K823318 | DENTAL INSTRUMENTS - EXCAVATORS | Miltex, Inc. | 1982-11-24 | Traditional | PDF ↗ |
| K822622 | ROOT CANAL FILES, TYPE H (HEDSTROM | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 | Traditional | PDF ↗ |
| K822621 | ROOT CANAL FILES, TYPE K | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 | Traditional | PDF ↗ |
| K812692 | FILES & REAMERS | Miltex Instrument Co. | 1981-10-23 | Traditional | PDF ↗ |
| K812260 | DYNA TRAK ENDODONTIC PREP. INSTRUMENT | Inventive Technology Int'L., Inc. | 1981-08-25 | Traditional | PDF ↗ |
| K800293 | FILE, PULP CANAL | Ipco Corp. | 1980-02-19 | Traditional | PDF ↗ |
Product code EKS · Class I · Dental. Data: openFDA.