Scaler, Ultrasonic

Product Code: ELC

Dental Ultrasonic Medical Devices (Miscellaneous)

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 872.4850


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as ELC

1239Scaler, UltrasonicUltrasonic Scaler.

Total Product Life Cycle (TPLC) Devices

1239Scaler, UltrasonicUltrasonic Scaler.

FDA Consensus Standards

Scaler, Ultrasonic [32309]21 CFR §872.4850 🔎
Scaler, Ultrasonic [34868]21 CFR §872.4850 🔎

Pre-market Notifications for ELC

K213947Ultrasonic Endo Activation Device (Model:Actor I Pro)ChangZhou BoMedent Medical Technology Co.,Ltd
K210832EVOCLEAN CLEANsert Ultrasonic InsertTTBIO CORP.
K203615Dental Scaler And Air PolisherGuilin Woodpecker Medical Instrument Co., Ltd.
K203302GentleWave XSonendo, Inc
K202906EndoPilot2Schlumbohm GmbH & Co. KG
K201317TTBIO EVOCLEAN Ultrasonic ScalerTTBIO CORP.
K191079Piezon Built-in Kit, Piezon Built-in Kit LEDE.M.S Electro Medical Systems S.A
K190359Sonendo GentleWave SystemSonendo, Inc.
K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW OneE.M.S Electro Medical Systems S.A.
K182145Tün® Ultrasonic Tips Product FamilyEngineered Endodontics
K171150AW-100Micron Corporation
K170104COMPACT S, COMPACT S (LED)DMETEC CO., LTD.
K163414Ultrasonic ScalerNANNING VV DENTAL CO., LTD.
K161639Y-MICMICRON CORPORATION
K160905Sonendo GentleWave SystemSONENDO, INC.

Global Unique Device Identification Database

00366975001047Scaler, Ultrasonic
00366975001030Scaler, Ultrasonic
00366975001023Scaler, Ultrasonic
00366975001016Scaler, Ultrasonic
00366975001009Scaler, Ultrasonic
00366975000996Scaler, Ultrasonic
00366975000989Scaler, Ultrasonic
00366975000972Scaler, Ultrasonic
00366975000965Scaler, Ultrasonic
00366975000958Scaler, Ultrasonic
00366975000941Scaler, Ultrasonic
00366975000934Scaler, Ultrasonic
00366975000927Scaler, Ultrasonic
00366975000910Scaler, Ultrasonic
00366975000903Scaler, Ultrasonic

Maude Adverse Events

CAVITRON SELECT SPS ULTRASONIC SCALERDENTSPLY LLC2020-03-24
CAVITRON PLUS PACKAGEDENTSPLY LLC2020-03-24
START-X TIPDENTSPLY MAILLEFER2020-03-24
CAVITRON SELECT SPS ULTRASONIC SCALERDENTSPLY LLC2020-03-24
SONENDO GENTLEWAVE SYSTEMSONENDO, INC.2020-03-21
SONENDO GENTLEWAVE SYSTEMSONENDO, INC.2020-03-21
SONENDO GENTLEWAVE SYSTEMSONENDO, INC.2020-03-21
START-X TIPDENTSPLY MAILLEFER2020-03-18
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-15
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-15
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER)DENTSPLY LLC2020-03-15
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER)DENTSPLY LLC2020-03-15
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 1000 (LOW-HIGH POWER)DENTSPLY LLC2020-03-15
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-14
CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEMDENTSPLY LLC2020-03-14
30K FOCUSED SPRAY SLIMLINE FITGRIP ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-14
CAVITRON SELECT SPS ULTRASONIC SCALERDENTSPLY LLC2020-03-14
START-X TIPDENTSPLY MAILLEFER2020-03-12
START-X TIPDENTSPLY MAILLEFER2020-03-11
START-X TIPDENTSPLY MAILLEFER2020-03-11
30K FOCUSED SPRAY POWERLINE ULTRASONIC INSERT - 100DENTSPLY LLC2020-03-11
PROULTRA ENDO TIP #5TULSA DENTAL PRODUCTS LLC2020-03-11
CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEMDENTSPLY LLC2020-03-11
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-11
30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-03-11
25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT)DENTSPLY LLC2020-03-04
PROULTRA ENDO TIP #5TULSA DENTAL PRODUCTS LLC2020-03-04
25K THRU FLOW ULTRASONIC INSERT (TFI) - 10 (STRAIGHT)DENTSPLY LLC2020-03-04
CAVITRON JET PLUS PACKAGEDENTSPLY LLC2020-03-02
START-X TIPDENTSPLY MAILLEFER2020-03-02
PROULTRA SINE TIP #5TULSA DENTAL PRODUCTS LLC2020-02-29
CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNITDENTSPLY LLC2020-02-29
CAVITRON SELECT SPS ULTRASONIC SCALERDENTSPLY LLC2020-02-29
25K FOCUSED SPRAY? SLIMLINE? ULTRASONIC INSERT - 10S STRAIGHTDENTSPLY LLC2020-02-27
START-X TIPDENTSPLY MAILLEFER2020-02-23
START-X TIPDENTSPLY MAILLEFER2020-02-22
START-X TIPDENTSPLY MAILLEFER2020-02-22
START-X TIPDENTSPLY MAILLEFER2020-02-22
START-X TIPDENTSPLY MAILLEFER2020-02-21
SONENDO GENTLEWAVE SYSTEMSONENDO2020-02-20
CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGYDENTSPLY LLC2020-02-19
CAVITRON JET SPS ULTRASONIC SCALER AND AIR POLISH SYSTEMDENTSPLY LLC2020-02-12
START-X TIPDENTSPLY MAILLEFER2020-02-12
CAVITRON 300 SERIES ULTRASONIC SCALING SYSTEM UNITDENTSPLY LLC2020-02-12
CAVITRON PLUS ULTRASONIC SCALERDENTSPLY LLC2020-02-12
START-X TIPDENTSPLY MAILLEFER2020-02-12
CAVITRON PLUS ULTRASONIC SCALER WITH TAP-ON TECHNOLOGYDENTSPLY LLC2020-02-12
PROULTRA ENDO TIP #5TULSA DENTAL PRODUCTS LLC2020-02-07
PROULTRA ENDO TIP #5TULSA DENTAL PRODUCTS LLC2020-02-07
CAVITRON PLUS PACKAGEDENTSPLY LLC2020-02-07
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