FDA Product Code
FDA Product Code KIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3820
510(k) Clearances — 147 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K063422 | BIOAGGREGATE | Innovative Bioceramix, Inc. | 2006-11-21 | Traditional | PDF ↗ |
| K060889 | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE | Pentron Clinical Technologies | 2006-10-27 | Traditional | PDF ↗ |
| K060946 | CZ-S2000 | Parkell, Inc. | 2006-06-15 | Traditional | PDF ↗ |
| K042769 | ADSEAL ROOT CANAL SEALER | Meta Biomed Co., Ltd. | 2004-11-24 | Traditional | PDF ↗ |
| K042756 | ENDOREZ | Ultradent Products, Inc. | 2004-10-26 | Special | PDF ↗ |
| K033585 | DIAPEX | Bisco, Inc. | 2004-01-16 | Traditional | PDF ↗ |
| K032662 | GUTTAFLOW | Coltene/Whaledent GmbH & Co. KG | 2003-11-03 | Traditional | PDF ↗ |
| K032605 | METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING | Meta Biomed Co., Ltd. | 2003-10-08 | Traditional | PDF ↗ |
| K032603 | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING | Meta Biomed Co., Ltd. | 2003-10-07 | Traditional | PDF ↗ |
| K023818 | FIBERFILL AGP | Pentron Clinical Technologies | 2003-04-03 | Traditional | PDF ↗ |
| K023976 | ACROSEAL ROOT CANAL OR APICAL SEALER | Septodont S.A.S. | 2003-01-30 | Traditional | PDF ↗ |
| K022734 | PULPDENT CALCIUM HYDROXIDE PREPARATION | Pulpdent Corporation | 2002-10-07 | Traditional | PDF ↗ |
| K011748 | FIRST FILL R.C.S. | Jeneric/Pentron, Inc. | 2001-08-03 | Traditional | PDF ↗ |
| K010940 | SEALAPEX 4 | Sybron Dental Specialties, Inc. | 2001-06-20 | Traditional | PDF ↗ |
| K011009 | WHITE MTA MATERIAL | Dentsply International | 2001-05-02 | Traditional | PDF ↗ |
| K992727 | THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM | Mds | 2000-01-18 | Traditional | PDF ↗ |
| K992097 | ENDOREZ | Ultradent Products, Inc. | 1999-10-26 | Traditional | PDF ↗ |
| K983037 | ROEKO SEAL | Roeko Ulm, Roescheisen GmbH & Co. | 1998-10-20 | Traditional | PDF ↗ |
| K981620 | MTA MATERIAL II | Dentsply Intl. | 1998-07-31 | Traditional | PDF ↗ |
| K980633 | ENDOSOLV E | Specialites Septodont | 1998-05-01 | Traditional | PDF ↗ |
| K980332 | MTA MATERIAL | Dentsply Intl. | 1998-02-24 | Traditional | PDF ↗ |
| K973667 | VITAPEX PRE-LOADED DENTAL SYRINGE | Neodental Chemical Products Co., Ltd. | 1997-11-06 | Traditional | PDF ↗ |
| K972369 | SEALAPEX | Sybron Dental Specialties, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K971899 | ENDO-SEAL | Ultradent Products, Inc. | 1997-06-26 | Traditional | PDF ↗ |
| K971622 | MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM | Mpl Technologies, Inc. | 1997-06-20 | Traditional | PDF ↗ |
| K964174 | MINERAL TRIOXIDE AGGREGATE (MTA) | Tulsa Dental Products, Ltd. | 1997-02-10 | Traditional | PDF ↗ |
| K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | Wallace A. Erickson & Co. | 1996-12-06 | Traditional | PDF ↗ |
| K962885 | SEALEX EXTRA ROOT CANAL SEALER | Baladent | 1996-08-30 | Traditional | PDF ↗ |
| K955703 | NEO DENTAL ENDODONTIC IRRIGATION SYRINGE | Neodental Chemical Products Co., Ltd. | 1996-05-20 | Traditional | PDF ↗ |
| K960548 | AH PLUS ROOT CANAL SEALER | Dentsply Intl. | 1996-04-26 | Traditional | PDF ↗ |
| K940368 | CANAL KING (THIN) CANAL KING (THICK) | Pulpdent Corp. | 1995-01-20 | Traditional | PDF ↗ |
| K946138 | PULPDENT ROOT CANAL SEALER | Pulpdent Corp. | 1995-01-20 | Traditional | PDF ↗ |
| K942393 | TUBLI-SEAL EWT | Sybron Dental Specialties, Inc. | 1994-06-10 | Traditional | PDF ↗ |
| K930872 | ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA | Wallace A. Erickson & Co. | 1994-02-01 | Traditional | PDF ↗ |
| K932791 | PULPDENT EDTA PREPARATIONS | Pulpdent Corp. | 1993-09-20 | Traditional | PDF ↗ |
| K914325 | ROOT CANAL FILLING CEMENT | Confi-Dental Products Co. | 1992-03-09 | Traditional | PDF ↗ |
| K896657 | ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K896656 | ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH | Pulpdent Corp. | 1990-02-14 | Traditional | PDF ↗ |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | The Hygenic Corp. | 1990-01-10 | Traditional | PDF ↗ |
| K893794 | APEXIT ROOT CANAL SEALER | Williams Dental Co., Inc. | 1989-11-29 | Traditional | PDF ↗ |
| K854253 | ROOT CANAL FILLING RESIN | Dentsply Intl. | 1985-12-16 | Traditional | PDF ↗ |
| K844635 | HYDROSET ROOT CANAL SEALER | Lund Manufacturing Co. | 1985-02-19 | Traditional | PDF ↗ |
| K830763 | FR ROOT CANAL FILLER | Shizai Corp. | 1983-08-26 | Traditional | PDF ↗ |
| K820284 | ROOT CANAL FILLING RESIN | Dentsply Intl. | 1982-03-19 | Traditional | PDF ↗ |
| K810923 | LEE ENDOFILL, ROOT CANAL FILLING RESIN | Lee Pharmaceuticals | 1981-04-21 | Traditional | PDF ↗ |
| K801482 | HYDRON ROOT CANAL FILLING MATERIAL | National Patent Development Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K771921 | HYDRON ROOT CANAL FILLING SYSTEM | National Patent Development Corp. | 1977-11-15 | Traditional | PDF ↗ |
Product code KIF · Class II · Dental. Data: openFDA.