Chrysalis Intelligence · Product Codes · EFB

EFB · Unclassified

24 clearances · 20 unique sponsors

Device class
Regulation —
Total clearances
24
2020-01-06 → 2026-01-12
Last 12 months
2
Unique sponsors
20
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Nakanishi, Inc. 4 0 2024-09-20
Foshan Topmed Dental Co., Ltd. 2 2 2026-01-12
Dentsply Sirona 1 0 2020-01-13
Litu Tech , Ltd. 1 0 2024-04-30
J. Morita USA, Inc. 1 0 2020-03-04
Ttbio Corp. 1 0 2023-08-23
Pac-Dent, Inc. 1 0 2022-12-12
Guilin Woodpecker Medical Instrument Co., Ltd. 1 0 2022-09-28
Dentalez, Inc. 1 0 2020-01-06
Guangdong Jinme Medical Technology Co., Ltd. 1 0 2024-11-13
Foshan Wenjian Medical Instrument Co., Ltd. 1 0 2020-05-26
Microp Technology (Taiwan), Inc. 1 0 2021-09-03
Shenzhen Carejoy Technology Co., Ltd. 1 0 2022-11-17
Beijing Dongbo Dental Handpiece Co., Ltd. 1 0 2021-11-08
Foshan Soco Precision Instrument Co., Ltd. 1 0 2024-11-12
Ningbo Hpdove Dental Instruments Co., Ltd. 1 0 2020-08-11
Jaintek Co.,Ltd 1 0 2022-07-15
W&H Dentalwerk Bürmoos GmbH 1 0 2025-02-28
Foshan Coxo Medical Instrument Co., Ltd. 1 0 2023-09-22
Saeshin Precision Co., Ltd. 1 0 2023-02-22
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.

CodeTypeDescriptionConfidenceRationale
D9000 HCPCS Low Air-powered handpiece is practice equipment, typically included in procedure overhead costs
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-01-12 K251389 Foshan Topmed Dental Co., Ltd. High speed air turbine handpiece
2026-01-12 K251388 Foshan Topmed Dental Co., Ltd. Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
2025-02-28 K242179 W&H Dentalwerk Bürmoos GmbH Synea Fusion Handpieces (Intensiv & Profin)
2024-11-13 K240337 Guangdong Jinme Medical Technology Co., Ltd. Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
2024-11-12 K241074 Foshan Soco Precision Instrument Co., Ltd. High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
2024-09-20 K241880 Nakanishi, Inc. Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
2024-04-30 K233122 Litu Tech , Ltd. High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
2024-04-25 K233308 Nakanishi, Inc. Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
2023-09-22 K220179 Foshan Coxo Medical Instrument Co., Ltd. High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors
2023-08-23 K232243 Ttbio Corp. EVO 700 series high speed handpiece
2023-06-02 K230888 Nakanishi, Inc. Titanium Turbine
2023-02-22 K221741 Saeshin Precision Co., Ltd. TRAUS Air Dental Handpiece
2022-12-12 K202674 Pac-Dent, Inc. Medidenta High Speed Handpieces
2022-11-17 K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
2022-09-28 K221548 Guilin Woodpecker Medical Instrument Co., Ltd. Dental Air Polishing Handpiece
2022-07-15 K221814 Jaintek Co.,Ltd OK Handpiece
2022-06-21 K203791 Nakanishi, Inc. Stainless Turbine
2021-11-08 K202371 Beijing Dongbo Dental Handpiece Co., Ltd. Highspeed Airturbine Handpiece
2021-09-03 K202786 Microp Technology (Taiwan), Inc. Dental Low-speed Handpieces and Accessories
2020-08-11 K193264 Ningbo Hpdove Dental Instruments Co., Ltd. Disposable High Speed Air Turbine Handpiece
2020-05-26 K181691 Foshan Wenjian Medical Instrument Co., Ltd. High-speed air turbine handpiece / Low-speed air turbine handpiece
2020-03-04 K190509 J. Morita USA, Inc. Lubrina 2
2020-01-13 K192409 Dentsply Sirona Midwest Rhino XE and Air Motor M
2020-01-06 K192412 Dentalez, Inc. SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece