Scaler, Ultrasonic
Regulation 872.4850
2510(k)s in 12 months (195 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in ELC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2024 | Dental EZ Group Star Dental Division Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669)
(1) P/N 264563
(2)
P/N 264565
The scaler tip is used with an air drive scaler for subgingival scaling and fine Open, Classified |
ELC | K881253 |
| Jun 24, 2024 | Dental EZ Group Star Dental Division Titan Scaler Tip - Perio
Model/Catalog Number: 261669
The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scalin Open, Classified |
ELC | K881253 |
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: PIEZON Bottle
Product Name: PIEZON Bottle
Model/Catalog Number: EG-111
Software Version: N/A
Product Description: These bottles are sold empty and are filled by the user with water - in so Open, Classified |
ELC | K190124 |
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: WATER BOTTLE
Product Name: WATER BOTTLE
Model/Catalog Number: EG-121
Software Version: N/A
Product Description: These bottles are sold empty and are filled by the user with water fort dent Open, Classified |
ELC | K190124 |
| Apr 24, 2024 | Electro Medical Systems SA Brand Name: CLEANER BOTTLE
Product Name: CLEANER BOTTLE
Model/Catalog Number: EG-1000
Software Version: N/A
Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW Open, Classified |
ELC | K190124 |
| Nov 14, 2022 | Sonendo Inc GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01 Open, Classified |
ELC | K190359 |
| Nov 14, 2022 | Sonendo Inc GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02 Open, Classified |
ELC | K190359 |
| Oct 23, 2019 | Sonendo Inc GENTLEWAVE REF: FG-002-0001 Terminated |
ELC | K190359 |
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light)
The intended use of the tips is based on the parent device. For the VarioSurg, in addition Terminated |
ELC | K073678 |
| Jul 8, 2016 | Nakanishi Inc. Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150).
The intended use of the tips is based on the parent device. For the ult Terminated |
ELC | K031421 |
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