LBH · Varnish, Cavity · Chrysalis Intelligence

Device class

Class II

Regulation 872.3260

Total clearances

2020-01-23 → 2026-06-11

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3260

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
Sangi Co., Ltd.	2	1	2026-03-18
Largent Health, LLC	2	0	2020-06-25
GreenMark Biomedical, Inc.	1	0	2025-01-02
Inter-Med, Inc.	1	0	2025-01-08
Belport Company, Inc., Gingi-Pak	1	0	2024-06-13
Scientific Pharmaceuticals	1	0	2020-02-18
Voco GmbH	1	1	2026-05-01
Ultradent Products, Inc.	1	1	2026-04-30
Theodent, LLC	1	0	2025-05-27
Kettenbach GmbH & Co. KG	1	0	2023-07-24
Ivoclar Vivadent, AG	1	0	2020-02-11
3M Espe Dental Products	1	0	2023-05-10
Dr. Collins, Inc.	1	0	2020-11-06
Centrix, Inc.	1	1	2025-11-21
Nagy Oral Technology Qinhuangdao Co., Ltd.	1	1	2026-06-11
Jasberry Healthcare Private Limited	1	0	2024-11-22
Guangzhou Beogene Biotech Co., Ltd.	1	0	2023-05-25
Elevate Oral Care	1	0	2024-07-18

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
99070	CPT	—	Medium	Supplies and materials provided by physician, could apply to cavity varnish material
D1120	CPT	—	Medium	CDT code for prophylaxis, but CPT/HCPCS mapping for fluoride varnish application often uses this dental preventive service

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-11	K253052	Nagy Oral Technology Qinhuangdao Co., Ltd.	Fluoride Varnish (Type A,Type C)
2026-05-01	K252073	Voco GmbH	VOCO Profluorid Varnish + BioMin
2026-04-30	K261404	Ultradent Products, Inc.	UltraEZ
2026-03-18	K260830	Sangi Co., Ltd.	APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
2025-11-21	K250714	Centrix, Inc.	FluoroDose Varnish
2025-05-27	K243777	Theodent, LLC	Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
2025-01-08	K241489	Inter-Med, Inc.	ReminGel
2025-01-02	K241568	GreenMark Biomedical, Inc.	CrystLCare PRO Biorestorative, Fluoride-Plus
2024-11-22	K242913	Jasberry Healthcare Private Limited	Jasmate® Toothpaste
2024-07-18	K233768	Elevate Oral Care	Papacarie Duo
2024-06-13	K231060	Belport Company, Inc., Gingi-Pak	ProMin Dental Desensitizing Gel
2023-07-24	K230333	Kettenbach GmbH & Co. KG	Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
2023-05-25	K222891	Guangzhou Beogene Biotech Co., Ltd.	Dental Desensitizer
2023-05-10	K231338	3M Espe Dental Products	3M Clinpro Clear 2.1% Sodium Fluoride Treatment
2022-02-16	K220419	Sangi Co., Ltd.	Apapro Desensitizer
2020-11-06	K200077	Dr. Collins, Inc.	BioMin Restore Plus
2020-06-25	K200614	Largent Health, LLC	FiteBac Antimicrobial Cavity Cleanser
2020-02-18	K192381	Scientific Pharmaceuticals	DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
2020-02-11	K191453	Ivoclar Vivadent, AG	Cervitec F
2020-01-23	K190271	Largent Health, LLC	FiteBac Cavity Cleanser