Chrysalis Intelligence · Product Codes · EIA

EIA · Unclassified

18 clearances · 17 unique sponsors

Device class
Regulation —
Total clearances
18
2020-02-05 → 2026-08-07
Last 12 months
2
Unique sponsors
17
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
Megagen Implant Co., Ltd. 2 0 2024-03-21
Olsen Indústria E Comércio S.A. 1 0 2022-10-19
Osstem Implant Company., Ltd. Chair Business 1 0 2025-07-17
Osstem Implant Co., Ltd. Chair Business 1 0 2024-09-03
Lares Research 1 0 2022-12-15
Dci International, LLC 1 0 2025-02-19
Foshan Safety Medical Equipment Co., Ltd. 1 0 2024-02-28
Midmark Corporation 1 1 2025-11-03
A-Dec, Inc. 1 0 2022-03-02
Firstar Dental Company 1 0 2025-01-27
Guangdong Yadeng Medical Apparatus Co., Ltd., 1 0 2025-06-27
Mipont Medical Equipment Co., Ltd. 1 0 2025-05-27
Shinhung Company, Ltd. 1 0 2023-04-03
Olsen Industria E Comercio S.A. 1 0 2020-02-05
Lakong Medical Devices Co., Ltd. 1 1 2026-08-07
Bdc Dental Corporation , Ltd. 1 0 2025-02-07
Mgnewton , Ltd. 1 0 2023-05-05
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
D6010 CPT High Dental chair equipment and operative unit setup; standard billing for dental operatory
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-07 K251544 Lakong Medical Devices Co., Ltd. Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
2025-11-03 K251626 Midmark Corporation Midmark Dental Delivery System
2025-07-17 K251491 Osstem Implant Company., Ltd. Chair Business K5 Cart, K5 Mount, K5 Swing
2025-06-27 K243130 Guangdong Yadeng Medical Apparatus Co., Ltd., Integral Dental Unit
2025-05-27 K242611 Mipont Medical Equipment Co., Ltd. Integral Dental Units
2025-02-19 K250473 Dci International, LLC Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
2025-02-07 K242404 Bdc Dental Corporation , Ltd. BDC Dental Unit
2025-01-27 K231297 Firstar Dental Company Firstar Dental Unit
2024-09-03 K233805 Osstem Implant Co., Ltd. Chair Business K5
2024-03-21 K240754 Megagen Implant Co., Ltd. N2
2024-02-28 K231845 Foshan Safety Medical Equipment Co., Ltd. Dental unit Model: Mare
2023-05-05 K202963 Mgnewton , Ltd. ELEC Master, ELEC Master Dual
2023-04-05 K211556 Megagen Implant Co., Ltd. N2
2023-04-03 K213749 Shinhung Company, Ltd. G7, Dental Operative Unit and Accessories
2022-12-15 K220873 Lares Research Perceptive electric dental motor and control unit
2022-10-19 K213742 Olsen Indústria E Comércio S.A. Infinity Pro, Logic, Quality, Sprint
2022-03-02 K213932 A-Dec, Inc. A-dec 300, A-dec 500
2020-02-05 K180935 Olsen Industria E Comercio S.A. Infinity / Infinity Cross Flex Dental Systems