FDA Product Code
FDA Product Code ELC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4850
510(k) Clearances — 195 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | Sirona Dental Systems GmbH | 2003-12-12 | Traditional | PDF ↗ |
| K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | Dentsply International | 2003-12-04 | Special | PDF ↗ |
| K032995 | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) | Micron Corp. | 2003-11-20 | Special | PDF ↗ |
| K031461 | CARRIER TIPS | Dentsply Intl. | 2003-08-05 | Traditional | PDF ↗ |
| K030111 | DIAMONDCOAT ULTRASONIC INSERTS | Dentsply International | 2003-02-07 | Special | PDF ↗ |
| K023697 | STERI-MATE STERILIZABLE HANDPIECE | Dentsply International | 2002-11-06 | Special | PDF ↗ |
| K022328 | EMS PIEZON MASTER 600 | Electro Medical Systems SA | 2002-08-13 | Special | PDF ↗ |
| K021253 | ULTRASONIC TIPS WITH DIAMOND COATING | Sybron Endo/Analytic | 2002-07-05 | Traditional | PDF ↗ |
| K014238 | DELSONIC 2000 | Deldent , Ltd. | 2002-01-24 | Traditional | PDF ↗ |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | Hu-Friedy Mfg. Co., Inc. | 2001-07-27 | Special | PDF ↗ |
| K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. | 2001-06-05 | Traditional | PDF ↗ |
| K010195 | PREMIER ULTRASONIC SCALER AND INSERTS | Premier Dental Products Co. | 2001-04-17 | Traditional | PDF ↗ |
| K002122 | VECTOR | Air Techniques, Inc. | 2000-12-21 | Traditional | PDF ↗ |
| K002753 | SPARTAN A-10 | Spartan Ultrasonics, Inc. | 2000-12-04 | Traditional | PDF ↗ |
| K000846 | TKD SCALERS | Orasystems | 2000-12-04 | Traditional | PDF ↗ |
| K002521 | SPARTAN MTS | Spartan Marketing Group | 2000-11-13 | Traditional | PDF ↗ |
| K000510 | ART-M1, MODEL M1-1-ART-A1 | Bonart Co., Ltd. | 2000-05-15 | Traditional | PDF ↗ |
| K994299 | ART-P3, MODEL P3-1-ART-A1 | Bonart Co., Ltd. | 2000-03-06 | Traditional | PDF ↗ |
| K994203 | ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1 | Bonart Co., Ltd. | 2000-03-06 | Traditional | PDF ↗ |
| K992504 | EMS KERMIT | (Ems Sa) Electro Medical Systems | 2000-01-27 | Traditional | PDF ↗ |
| K990546 | DELSONIC 2000 | Sds Dental, Inc. | 1999-11-05 | Traditional | PDF ↗ |
| K991239 | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 | Micron Corp. | 1999-10-18 | Traditional | PDF ↗ |
| K991874 | EMS SURFACE MOUNT SCALER | (Ems Sa) Electro Medical Systems | 1999-07-30 | Traditional | PDF ↗ |
| K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | Nsk Nakanishi, Inc. | 1999-06-23 | Traditional | PDF ↗ |
| K983029 | POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001 | Tpc Advanced Technology, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | Coltene/Whaledent, Inc. | 1999-01-20 | Traditional | PDF ↗ |
| K982793 | PIEZO TRONIC | Advanced Medical Devices, Inc. | 1998-10-28 | Traditional | PDF ↗ |
| K972026 | SP4044 & SP4055 LUX MODULES | Satelec | 1997-07-09 | Traditional | PDF ↗ |
| K964596 | PROSELECT 3 PERIDONTAL THERAPY SYSTEM | Professional Dental Mfg., Inc. | 1997-04-22 | Traditional | PDF ↗ |
| K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | Dentsply Intl. | 1997-04-11 | Traditional | PDF ↗ |
| K970342 | CAVITRON JET WITH SPS SYSTEM | Dentsply Intl. | 1997-04-04 | Traditional | PDF ↗ |
| K964320 | TONY RISO 25/30 MULTIFUNCTION SCALER | Tony Riso Co., Inc. | 1997-01-23 | Traditional | PDF ↗ |
| K961158 | SUPRASSON P5 BOOSTER | Satelec | 1996-05-23 | Traditional | PDF ↗ |
| K960889 | SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS | San Diego Swiss Machining, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K943403 | CONDOR ULTRASONIC INSERTS | Condor Products, Inc. | 1996-03-05 | Traditional | PDF ↗ |
| K954820 | SCALEX 800 | Dentamerica | 1996-01-18 | Traditional | PDF ↗ |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | Hu-Friedy Mfg. Co., Inc. | 1995-10-07 | Traditional | PDF ↗ |
| K942139 | SUPRASSON P MAX | Satelec | 1995-09-29 | Traditional | PDF ↗ |
| K953026 | MINIPIEZON | Electro Medical Systems SA | 1995-08-28 | Traditional | PDF ↗ |
| K942380 | MICRO ICS SONIC SCALER | Micro Motors, Inc. | 1995-08-07 | Traditional | PDF ↗ |
| K951272 | RELACS 7000 | Micro-Mega Societe Anonyme | 1995-05-12 | Traditional | PDF ↗ |
| K950240 | LE CLEAN MACHINE | Parkell, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K950256 | TURBO 25/30 | Parkell, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K941392 | JET UNIT (CJ HANDPIECE) | Dentsply Intl. | 1994-05-23 | Traditional | PDF ↗ |
| K934714 | ENDODONTIC PULP CANAL SPREADER | Excellence IN Endodontics, Inc. | 1994-02-14 | Traditional | PDF ↗ |
| K933547 | INTRA-ORAL IRRIGATOR | Parkell, Inc. | 1993-10-20 | Traditional | PDF ↗ |
| K920328 | AMDENT 2030, POLISHER/SCALER | Amdent AB | 1993-10-20 | Traditional | PDF ↗ |
| K930698 | THE MODEL 3003 SCALER | Dentsply Intl. | 1993-07-22 | Traditional | PDF ↗ |
| K921893 | COLGATE ODONTOSON ULTRASONIC SCALER | Perio-Giene | 1993-07-08 | Traditional | PDF ↗ |
| K923639 | DIAMOND COATED DENTAL INSERTS | Dentsply Intl. | 1992-10-26 | Traditional | PDF ↗ |
| K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | Micro Motors, Inc. | 1991-04-16 | Traditional | PDF ↗ |
| K904296 | LYSTA HYGIENIST III SCALER | Prodent Intl., Inc. | 1990-12-05 | Traditional | PDF ↗ |
| K903163 | PERIODONTAL DEBRIDING SOLUTION E | Dentsply Intl. | 1990-10-10 | Traditional | PDF ↗ |
| K896749 | PIEZON MASTER 400 | Electro Medical Systems (Ems Sa) | 1990-08-31 | Traditional | PDF ↗ |
| K902413 | SONIC SCALER | Dentsply Intl. | 1990-08-13 | Traditional | PDF ↗ |
| K901488 | LYNX-SM, SCLAER DENTAL HANDPIECE | Mti Precision Products | 1990-05-15 | Traditional | PDF ↗ |
| K900709 | AIR FLOW SII | Electro Medical Systems (Ems Sa) | 1990-04-18 | Traditional | PDF ↗ |
| K894247 | PERIODONTAL IRRIGATING SOLUTION-D | Dentsply Intl. | 1989-10-06 | Traditional | PDF ↗ |
| K884221 | ULTRASONIC SCALER COVER | Steri-Shield Products, Inc. | 1989-03-17 | Traditional | PDF ↗ |
| K880940 | AMDENT MODEL 830 ULTRASONIC SCALER | Pathway Products, Inc. | 1988-07-15 | Traditional | PDF ↗ |
| K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | Dentalez Group | 1988-04-21 | Traditional | PDF ↗ |
| K873146 | USI BASIC. AG 1050. AG 1090 | Cranston Ind., Inc. | 1987-10-27 | Traditional | PDF ↗ |
| K864996 | ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 | Dentsply Intl. | 1987-02-19 | Traditional | PDF ↗ |
| K863676 | GENTEEL | Luben Dental Co., Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K853841 | HARMO SONIC | U.S. Shizai Corp. | 1986-02-04 | Traditional | PDF ↗ |
| K852525 | SATALEC PIEZOTEC | Spelna, Inc. | 1986-01-30 | Traditional | PDF ↗ |
| K852540 | ULTRASONIC TOOTH SCALER MODEL DSCIOP | Parkell, Inc. | 1985-07-01 | Traditional | PDF ↗ |
| K844250 | OSADA ENAC | Osada Electric Co., Ltd. | 1985-01-23 | Traditional | PDF ↗ |
| K842581 | CAVI-MED | Cooper Lasersonics, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K832674 | SATELEC PROPHY UNIT PU 2000S | Spelna, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K840141 | DENTAL ULTRASONIC SCALER/ENDOSONIC | CooperVision, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K832664 | SATELEC SUPRASSON PIEZOMATIC P2 | Spelna, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K834283 | DENTSPLY G-106 CAVITRON ULTRASONIC | Coopercare, Inc. | 1984-03-16 | Traditional | PDF ↗ |
| K832665 | SATELEC SUPRASSON SP 3055 | Spelna, Inc. | 1983-10-19 | Traditional | PDF ↗ |
| K832443 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | California Technics, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K823134 | AIR FLOW II | Healthco, Inc. | 1982-11-17 | Traditional | PDF ↗ |
| K821810 | PIEZON ULTRASONIC SCALER | Healthco, Inc. | 1982-07-06 | Traditional | PDF ↗ |
| K820162 | TEC-SON II | California Technics, Inc. | 1982-02-24 | Traditional | PDF ↗ |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Fibra Sonics, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K811396 | SONUS V | California Technics, Inc. | 1981-06-26 | Traditional | PDF ↗ |
| K811145 | PNEUMATIC DENTAL SCALER | Innovate, Inc. | 1981-06-16 | Traditional | PDF ↗ |
| K811023 | ROOT CANAL KIT | Dentsply Intl. | 1981-05-05 | Traditional | PDF ↗ |
| K801689 | SONATRON ULTRASONIC DENTAL SCANNER | Simplified Systems, Inc. | 1980-09-16 | Traditional | PDF ↗ |
| K791704 | MASTERSCALE II | Litton Dental Products | 1979-10-26 | Traditional | PDF ↗ |
| K791585 | MODEL G-61 ULTRASONIC DENTAL UNIT | Cavitron Corp. | 1979-09-19 | Traditional | PDF ↗ |
| K791024 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | Litton Dental Products | 1979-09-17 | Traditional | PDF ↗ |
| K782133 | ODONTOSON 3 | Mdt Corp., Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K781044 | ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM | Litton Dental Products | 1978-06-30 | Traditional | PDF ↗ |
| K780808 | PIEZOMATIC ULTRASONIC SCALER (SYSTEM S) | Dental Ventures of America, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K771556 | EXR | Litton Dental Products | 1977-08-22 | Traditional | PDF ↗ |
| K771557 | ULTRASON 990 | Litton Dental Products | 1977-08-19 | Traditional | PDF ↗ |
| K761247 | LT:200, LOVING TOUCH | Litton Dental Products | 1976-12-16 | Traditional | PDF ↗ |
| K761246 | SONUS III | Litton Dental Products | 1976-12-16 | Traditional | PDF ↗ |
| K760805 | ULTRASONIC DENTAL PROPHYLAXIS DEVICE | Cavitron Corp. | 1976-10-21 | Traditional | PDF ↗ |
| K760445 | DENTAL PROPHYLAXIS UNIT ULTRASONIC | Branson Ultrasonics Corp. | 1976-08-26 | Traditional | PDF ↗ |
Product code ELC · Class II · Dental. Data: openFDA.