Product code ELC— Dental
Sonendo GentleWave System
- Classification name
- Scaler, Ultrasonic
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Total cleared
- 195
- First cleared
- Most recent
Clearances under product code ELC — page 2
101–195 of 195- K033640 — SIROSON L AND SIROSONIC L ULTRASONIC SCALERS
- K033705 — BOBCAT PRO SCALER SYSTEM, MODEL G-130
- K032995 — SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)
- K031461 — CARRIER TIPS
- K030111 — DIAMONDCOAT ULTRASONIC INSERTS
- K023697 — STERI-MATE STERILIZABLE HANDPIECE
- K022328 — EMS PIEZON MASTER 600
- K021253 — ULTRASONIC TIPS WITH DIAMOND COATING
- K014238 — DELSONIC 2000
- K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
- K011179 — DELDENT ULTRASONIC INSERTS
- K010195 — PREMIER ULTRASONIC SCALER AND INSERTS
- K002122 — VECTOR
- K000846 — TKD SCALERS
- K002753 — SPARTAN A-10
- K002521 — SPARTAN MTS
- K000510 — ART-M1, MODEL M1-1-ART-A1
- K994203 — ART-M3 25K, MODEL M3-1-ART2-A1; ART-M3 30K, MODEL M3-1-ART3-A1
- K994299 — ART-P3, MODEL P3-1-ART-A1
- K992504 — EMS KERMIT
- K990546 — DELSONIC 2000
- K991239 — VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
- K991874 — EMS SURFACE MOUNT SCALER
- K991021 — SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
- K983029 — POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
- K983727 — BIOSONIC ULTRASONIC SCALER SYSTEM
- K982793 — PIEZO TRONIC
- K972026 — SP4044 & SP4055 LUX MODULES
- K964596 — PROSELECT 3 PERIDONTAL THERAPY SYSTEM
- K970123 — DENTSPLY CAVITRON SPS SCALER SYSTEM
- K970342 — CAVITRON JET WITH SPS SYSTEM
- K964320 — TONY RISO 25/30 MULTIFUNCTION SCALER
- K961158 — SUPRASSON P5 BOOSTER
- K960889 — SAPPHIRE PLUS SCALER MOD. 300114/PLUGGER MOD. 300115/CUTTING MOD. 300116/SPREADER MOD. 300117 TIPS
- K943403 — CONDOR ULTRASONIC INSERTS
- K954820 — SCALEX 800
- K953919 — DENTAL ULTRASONIC SCALER INSERTS
- K942139 — SUPRASSON P MAX
- K953026 — MINIPIEZON
- K942380 — MICRO ICS SONIC SCALER
- K951272 — RELACS 7000
- K950240 — LE CLEAN MACHINE
- K950256 — TURBO 25/30
- K941392 — JET UNIT (CJ HANDPIECE)
- K934714 — ENDODONTIC PULP CANAL SPREADER
- K920328 — AMDENT 2030, POLISHER/SCALER
- K933547 — INTRA-ORAL IRRIGATOR
- K930698 — THE MODEL 3003 SCALER
- K921893 — COLGATE ODONTOSON ULTRASONIC SCALER
- K923639 — DIAMOND COATED DENTAL INSERTS
- K903298 — DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP
- K904296 — LYSTA HYGIENIST III SCALER
- K903163 — PERIODONTAL DEBRIDING SOLUTION E
- K896749 — PIEZON MASTER 400
- K902413 — SONIC SCALER
- K901488 — LYNX-SM, SCLAER DENTAL HANDPIECE
- K900709 — AIR FLOW SII
- K894247 — PERIODONTAL IRRIGATING SOLUTION-D
- K884221 — ULTRASONIC SCALER COVER
- K880940 — AMDENT MODEL 830 ULTRASONIC SCALER
- K881253 — ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW
- K873146 — USI BASIC. AG 1050. AG 1090
- K864996 — ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30
- K863676 — GENTEEL
- K853841 — HARMO SONIC
- K852525 — SATALEC PIEZOTEC
- K852540 — ULTRASONIC TOOTH SCALER MODEL DSCIOP
- K844250 — OSADA ENAC
- K842581 — CAVI-MED
- K832664 — SATELEC SUPRASSON PIEZOMATIC P2
- K832674 — SATELEC PROPHY UNIT PU 2000S
- K834283 — DENTSPLY G-106 CAVITRON ULTRASONIC
- K840141 — DENTAL ULTRASONIC SCALER/ENDOSONIC
- K832665 — SATELEC SUPRASSON SP 3055
- K832443 — ULTRASONIC DENTAL PROPHYLAXIS UNIT
- K823134 — AIR FLOW II
- K821810 — PIEZON ULTRASONIC SCALER
- K820162 — TEC-SON II
- K812909 — HYGIENTIST; CYCLOSON I & II; RETROFIT
- K811396 — SONUS V
- K811145 — PNEUMATIC DENTAL SCALER
- K811023 — ROOT CANAL KIT
- K801689 — SONATRON ULTRASONIC DENTAL SCANNER
- K791704 — MASTERSCALE II
- K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT
- K791024 — ULTRASONIC DENTAL PROPHYLAXIS UNIT
- K782133 — ODONTOSON 3
- K781044 — ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM
- K780808 — PIEZOMATIC ULTRASONIC SCALER (SYSTEM S)
- K771556 — EXR
- K771557 — ULTRASON 990
- K761246 — SONUS III
- K761247 — LT:200, LOVING TOUCH
- K760805 — ULTRASONIC DENTAL PROPHYLAXIS DEVICE
- K760445 — DENTAL PROPHYLAXIS UNIT ULTRASONIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.