KLE · Agent, Tooth Bonding, Resin · Chrysalis Intelligence

Device class

Class II

Regulation 872.3200

Total clearances

2020-02-07 → 2026-05-14

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.3200

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
Rizhao Huge Biomaterials Company, Ltd.	4	0	2024-12-20
DiaDent Group International	4	0	2022-06-15
Ivoclar Vivadent, AG	2	1	2026-03-05
Mediclus Co., Ltd.	2	1	2026-05-14
Belport Company, Inc., Gingi-Pak	2	1	2026-04-10
GC America, Inc.	2	1	2025-10-02
Spident Co., Ltd.	2	0	2024-11-01
Denmat Holding, LLC	1	0	2022-08-09
Tokuyama Dental Corporation	1	0	2021-05-25
Premier Dental Products Company	1	1	2026-03-03
Sincera Technology (Changchun) Co., Ltd.	1	0	2024-07-16
Kuraray Noritake Dental, Inc.	1	0	2023-12-13
Prevest Denpro Limited	1	0	2023-08-11
Saremco Dental AG	1	1	2025-12-05
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS	1	0	2021-01-19
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	1	1	2026-02-23
Rounding Third, LLC	1	0	2022-01-28
Sino-Dentex Co., Ltd.	1	0	2023-09-22
Genoss Co., Ltd.	1	0	2020-10-28
Shofu Dental Corporation	1	0	2022-03-18
Liaoning Upcera Co., Ltd.	1	0	2024-10-02
Meta Biomed Co., Ltd.	1	0	2023-03-03
Pac-Dent, Inc.	1	0	2021-07-16
Ultradent Products, Inc.	1	0	2024-03-20
Kerr Corporation	1	0	2023-01-12

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
D1999	CPT	—	Medium	ADA CDT code for unlisted adjunctive procedure (tooth bonding is often included in restorative codes)
D2390	CPT	—	Medium	ADA CDT code for resin-based composite - one surface, posterior (includes bonding agent)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-14	K260485	Mediclus Co., Ltd.	Any-Etch
2026-04-10	K260430	Belport Company, Inc., Gingi-Pak	Porcelain Etch Gel
2026-03-05	K252450	Ivoclar Vivadent, Inc.	Adhese 2
2026-03-03	K260682	Premier Dental Products Company	Bond-PR Universal Adhesive
2026-02-23	K251587	Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	VITA VMLC Primer
2025-12-05	K252151	Saremco Dental AG	els unibond
2025-11-06	K252469	Dmp Dental Industry S.A.	MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
2025-10-02	K251124	GC America, Inc.	G-Bond Universal
2024-12-20	K242530	Rizhao Huge Biomaterials Company, Ltd.	HF-Etchant Hydrofluoric Acid Etching Gel
2024-11-08	K242749	Rizhao Huge Biomaterials Company, Ltd.	TopCEM Ceramic Primer Ceramic Coupling Agent
2024-11-01	K242675	Spident Co., Ltd.	FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
2024-10-02	K240153	Liaoning Upcera Co., Ltd.	Ceramic Etchant (HF-5 and HF-9)
2024-07-22	K241445	Spident Co., Ltd.	K-Bond Universal
2024-07-16	K241056	Sincera Technology (Changchun) Co., Ltd.	Light Cure Adhesive
2024-03-20	K240743	Ultradent Products, Inc.	Peak Universal Bond
2023-12-13	K231039	Kuraray Noritake Dental, Inc.	CLEARFIL Universal Bond Quick 2
2023-09-22	K232978	Sino-Dentex Co., Ltd.	DX. Bond V Dental Bonding Adhesive
2023-08-11	K231696	Prevest Denpro Limited	Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
2023-05-22	K230465	Mediclus Co., Ltd.	Hi-Bond Universal
2023-03-03	K230009	Meta Biomed Co., Ltd.	EZ Bond Universal
2023-01-12	K222830	Kerr Corporation	Rainbow 360
2022-09-12	K221450	Rizhao Huge Biomaterials Company, Ltd.	Phosphoric Acid Etching Gel
2022-08-09	K222357	Denmat Holding, LLC	DenMat Glutaraldehyde Desensitizer
2022-07-06	K221033	S&C Polymer Silicon- Und Composite Spezialitäten GmbH	UniPrime A, UniPrime E, UniPrime E/C
2022-06-15	K220804	DiaDent Group International	Dia-X Bond Universal