KIF · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-03-27 → 2026-06-29

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Meta Biomed Co., Ltd.	4	0	2023-09-29
Mediclus Co., Ltd.	4	1	2026-01-12
DiaDent Group International	4	0	2021-03-25
Maruchi	3	0	2023-02-14
Inter-Med, Inc.	2	0	2024-08-28
Innovative Bioceramix, Inc.	2	0	2023-05-31
Enpuno Biotechnology Co., Ltd.	2	1	2025-09-25
Septodont	2	0	2021-09-16
Longly Biotechnology (Wuhan) Co., Ltd.	2	0	2024-12-12
Beijing C-Root Dental Medical Devices Co., Ltd.	2	0	2024-05-10
Voco GmbH	1	0	2025-07-03
Genoss Co., Ltd.	1	0	2023-07-28
Lumendo AG	1	0	2023-07-10
Shiva Products	1	0	2024-07-30
Essential Dental Systems	1	0	2021-02-12
Guilin Kevin Peter Technology Co., Ltd.	1	1	2026-06-29
Vericom Co., Ltd.	1	1	2025-09-19
Ultradent Products, Inc.	1	0	2021-10-13
Angelus Industria DE Produtos Odontologicos S/A	1	0	2021-02-11
Sprig Oral Health Technologies, Inc.	1	0	2023-03-24
Sonendo, Inc.	1	0	2021-08-27
Spident Co., Ltd.	1	0	2024-11-07
Prevest Denpro Limited	1	0	2022-05-23
Enpuno Co., Ltd.	1	0	2025-06-11
Kerr Corporation	1	1	2026-01-07

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
D3110	CPT	—	High	ADA CDT code for pulpal debridement, primary and permanent teeth; root canal filling material
D3310	CPT	—	High	ADA CDT code for endodontic therapy with pulpal debridement and root canal filling

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-29	K261415	Guilin Kevin Peter Technology Co., Ltd.	Injectable Root Canal Sealer (KP-Root SP)
2026-01-12	K253167	Mediclus Co., Ltd.	Any-Paste
2026-01-07	K252890	Kerr Corporation	ZenSeal Pro
2025-09-25	K251465	Enpuno Biotechnology Co., Ltd.	Root canal repair materials (nRoot BP)
2025-09-19	K252285	Vericom Co., Ltd.	Well-Root PT
2025-08-22	K251884	Mediclus Co., Ltd.	One-Fil Putty Injectable
2025-07-03	K251390	Voco GmbH	MTA vpt
2025-06-11	K250710	Enpuno Co., Ltd.	Injectable Root Canal Bioceramic Sealer (nRoot SP)
2025-03-14	K243353	Mediclus Co., Ltd.	One-Fil Putty
2025-02-13	K243546	Dentsply Sirona, Inc.	AH Plus Endodontic Sealer
2024-12-12	K242934	Longly Biotechnology (Wuhan) Co., Ltd.	Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
2024-11-07	K242702	Spident Co., Ltd.	VioSeal
2024-10-03	K241977	Longly Biotechnology (Wuhan) Co., Ltd.	Injectable Root Canal Bioceramic Sealer (i-MTA SP)
2024-08-28	K241457	Inter-Med, Inc.	Vista BC Putty
2024-07-30	K240446	Shiva Products	Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
2024-05-28	K240304	Enpuno Biotechnology Co., Ltd.	Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
2024-05-10	K240365	Beijing C-Root Dental Medical Devices Co., Ltd.	Bioceramic Root Repair Material (C-Root BP)
2024-01-26	K232182	Mediclus Co., Ltd.	One-Fil
2023-09-29	K232299	Meta Biomed Co., Ltd.	CeraPutty
2023-07-28	K231480	Genoss Co., Ltd.	Bright MTA Sealer Plus
2023-07-10	K231387	Lumendo AG	Endofill
2023-05-31	K231259	Innovative Bioceramix, Inc.	iRoot SP Plus
2023-04-13	K230010	Meta Biomed Co., Ltd.	ADSEAL Plus
2023-03-24	K230797	Sprig Oral Health Technologies, Inc.	SmartMTA Capsule
2023-02-14	K213757	Maruchi	Endocem MTA Premixed Regular

KIF · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances