ELC · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-12-04 → 2026-03-10

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Ttbio Corp.	2	0	2022-02-02
Nakanishi, Inc.	2	2	2026-03-10
Dent4you AG	1	0	2024-07-01
E.M.S Electro Medical Systems S.A	1	1	2026-01-28
Shenzhen Micro Electric Intelligence Co., Ltd.	1	0	2024-07-02
Mectron S.P.A.	1	0	2023-05-15
Essential Dental Systems, Inc.	1	0	2023-12-11
Denjoy Dental Co., Ltd.	1	0	2025-02-13
Sonendo, Inc.	1	0	2021-02-05
Odne AG	1	0	2024-08-08
Foshan Coxo Medical Instrument Co., Ltd.	1	0	2023-03-23
Schlumbohm GmbH & Co. KG	1	0	2021-04-13
W&H Dentalwerk Buermoss GmbH	1	0	2023-07-14
Guilin Woodpecker Medical Instrument Co., Ltd.	1	0	2021-12-10
Changzhou Bomedent Medical Technology Co.,Ltd	1	0	2022-09-08
Satelec - Acteon Group	1	0	2024-03-11
Guilin Refine Medical Instrument Co., Ltd.	1	0	2023-11-21

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
D4341	CPT	—	High	Periodontal scaling and root planing—four or more teeth per quadrant; ultrasonic scaler standard billing
D1110	CPT	—	Medium	Prophylaxis—adult; scaler may also be used for routine prophy

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-10	K260773	Nakanishi, Inc.	Varios Combi Pro2
2026-01-28	K253254	E.M.S Electro Medical Systems S.A	GBT Machine Airflow Prophylaxis Master
2025-09-19	K251689	Nakanishi, Inc.	VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)
2025-02-13	K242317	Denjoy Dental Co., Ltd.	Integrated Endo System (Meet Endo-II)
2024-08-08	K233844	Odne AG	OdneClean
2024-07-02	K240707	Shenzhen Micro Electric Intelligence Co., Ltd.	Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)
2024-07-01	K240801	Dent4you AG	BioSonic US200 Ultrasonic Scaler (60034537)
2024-03-11	K233922	Satelec - Acteon Group	SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
2023-12-11	K223340	Essential Dental Systems, Inc.	EDS Calculus Softener TURBO CR
2023-11-21	K230641	Guilin Refine Medical Instrument Co., Ltd.	Ultrasonic Scaler Tips
2023-07-14	K223173	W&H Dentalwerk Buermoss GmbH	Proxeo ULTRA (PB-510, PB-520 and PB-530)
2023-05-15	K231391	Mectron S.P.A.	Combi Touch
2023-03-23	K222096	Foshan Coxo Medical Instrument Co., Ltd.	Endo Ultrasonic Activator
2022-09-08	K213947	Changzhou Bomedent Medical Technology Co.,Ltd	Ultrasonic Endo Activation Device (Model:Actor I pro)
2022-02-02	K210832	Ttbio Corp.	EVOCLEAN CLEANsert Ultrasonic Insert
2021-12-10	K203615	Guilin Woodpecker Medical Instrument Co., Ltd.	Dental Scaler and Air Polisher
2021-04-13	K202906	Schlumbohm GmbH & Co. KG	EndoPilot2
2021-02-05	K203302	Sonendo, Inc.	GentleWave X
2020-12-04	K201317	Ttbio Corp.	TTBIO EVOCLEAN Ultrasonic Scaler

ELC · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances