LRK · Device, Anti-Snoring · Chrysalis Intelligence

Device class

Class II

Regulation 872.5570

Total clearances

2020-01-03 → 2026-07-31

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.5570

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
Good Sleep CO Pte , Ltd.	3	2	2025-11-25
Fissiontech, LLC	3	1	2025-10-29
Prismatik Dentalcraft, Inc.	3	0	2023-11-14
Vivos Therapeutics, Inc.	3	0	2024-09-16
Prosomnus Sleep Technologies, Inc.	2	0	2022-10-06
The Tmj Clinic PC	2	1	2025-09-17
Respire Medical Holdings	2	0	2022-05-31
Koncept Innovators, LLC	2	1	2026-05-14
Orthoapnea S.L.	2	0	2021-02-25
Aiomega, LLC	1	1	2025-11-06
Mpowrx Health and Wellness Products 2012, Inc.	1	0	2020-01-03
Diamond Orthotic Laboratory	1	0	2020-09-03
Greystone Ip, Ltd.	1	0	2022-09-08
Shinrin-Yoku Traders, LLC	1	0	2022-12-02
Dasoft Partners	1	0	2021-02-19
Snorebandit, LLC	1	0	2021-07-01
Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)	1	0	2021-08-19
Oniris	1	1	2025-09-04
Nightguard Express, LLC	1	1	2025-11-03
Dental Choice Holdings, LLC	1	0	2022-10-27
Ram.Shaw Pte. , Ltd.	1	1	2026-03-03
Shaeferh, LLC	1	1	2026-04-10
Dongguan Yiyao Science & Technology Development Co., Ltd.	1	1	2025-10-03
Park Dental Research Corp.	1	1	2025-12-18
Ema Sleep Incorporated	1	0	2024-05-03

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
D8999	HCPCS	—	Low	Dental device/appliance not elsewhere classified; anti-snoring appliance

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K261912	DnB Innovations, LLC	SnØreNegatØr
2026-06-12	K261366	Somnomed, Inc.	Virtus
2026-06-11	K261251	Endeavor Commerce, LLC	Snorbliss® Anti-Snoring Device
2026-05-14	K261134	Koncept Innovators, Inc.	Dormiva Anti-Snoring Mouth Guard
2026-04-10	K252942	Shaeferh, LLC	ShaeferH
2026-03-03	K253845	Ram.Shaw Pte. , Ltd.	Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
2026-03-02	K252531	Myofunctional Research Co.	Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
2025-12-18	K252976	Park Dental Research Corp.	Park Dental Nylon MAD
2025-12-05	K253868	QuietLab, LLC	QuietLab Pro
2025-11-25	K252161	Good Sleep CO Pte , Ltd.	Hushd Avera
2025-11-06	K252525	Aiomega, LLC	AIO Breathe
2025-11-03	K252698	Nightguard Express, LLC	NightGuard Aire Max
2025-10-29	K253355	Fissiontech, LLC	Difiney Advanced Anti Snoring Device 4.0
2025-10-24	K251784	Good Sleep CO Pte , Ltd.	Hushd Pro Z-Link
2025-10-22	K251628	Dcstar, Inc.	Mandibular Advancement Device L07
2025-10-03	K250028	Dongguan Yiyao Science & Technology Development Co., Ltd.	Anti Snore Mouthpiece
2025-09-17	K243752	The Tmj Clinic PC	Double Tube Herbst Appliance
2025-09-11	K252374	Airway Technologies D/B/A Airway Management	Nylon flexTAP(R)
2025-09-04	K250353	Oniris	Oniris; Oniris Plus
2025-05-19	K250122	Splintek, Inc.	SleepRight Snore Aid
2025-05-08	K250482	Fissiontech, LLC	Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
2024-09-16	K234089	Vivos Therapeutics	DNA Appliance
2024-05-09	K232025	Good Sleep CO Pte , Ltd.	Hushd Pro Avera
2024-05-03	K232735	Ema Sleep Incorporated	EMA 3D
2024-04-18	K233850	Fissiontech, LLC	Difiney Anti Snoring Device