Chrysalis Intelligence · Product Codes · EMA

EMA · Cement, Dental

Dental · 40 clearances · 24 unique sponsors

Device class
Class II
Regulation 872.3275
Total clearances
40
2020-01-23 → 2026-08-13
Last 12 months
12
Unique sponsors
24
Medical specialty
Dental
Review panel
DE
Regulation number
872.3275
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Shofu Dental Corporation 5 2 2025-12-09
GC America, Inc. 4 2 2026-05-18
Rizhao Huge Biomaterials Company, Ltd. 3 1 2025-12-12
Voco GmbH 3 1 2026-03-20
Dentsply Sirona 2 0 2024-04-02
DiaDent Group International 2 1 2026-07-09
Spident Co., Ltd. 2 0 2025-06-20
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS 2 0 2022-08-09
Bisco, Inc. 2 0 2025-07-11
DMG Chemisch-Pharmazeutische Fabrik GmbH 1 0 2022-06-01
Sdi Limited 1 0 2022-08-30
Vericom Co., Ltd. 1 0 2020-08-21
Kulzer, LLC 1 1 2025-12-19
Belport Company, Inc., Gingi-Pak 1 1 2025-09-02
Parkell, Inc. 1 0 2022-01-20
Mediclus Co., Ltd. 1 1 2026-08-13
Overfibers S.R.L. 1 0 2025-01-10
The Belport Company Inc., DBA Gingi-Pak 1 1 2026-08-07
Inter-Med, Inc. 1 1 2026-04-15
Ultradent Products, Inc. 1 0 2021-07-13
Doxa Dental AB 1 0 2020-11-13
Cosmedent, Inc. 1 0 2024-07-24
Kuraray Noritake Dental, Inc. 1 0 2021-06-11
Prevest Denpro Limited 1 0 2021-05-13
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
D2391 CPT Medium Resin-based composite—one surface, posterior; cement is supply component of restoration
D6010 CPT Medium Dental supplies/materials; cement often considered consumable bundled to procedure
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-08-13 K254201 Mediclus Co., Ltd. Any-Cem
2026-08-07 K261937 The Belport Company Inc., DBA Gingi-Pak PacTemp Automix NE
2026-07-09 K261166 DiaDent Group International DIA-CEM
2026-05-18 K254109 GC America, Inc. G-CEM UNIVERSAL
2026-04-15 K253337 Inter-Med, Inc. REGEN Bioactive Cement
2026-03-20 K252606 Voco GmbH Bifix Veneer LC, Bifix Veneer Try-In
2025-12-19 K254063 Kulzer, LLC iCEM Universal Plus
2025-12-12 K252785 Rizhao Huge Biomaterials Company, Ltd. TopCEM Vigor SA Self-Adhesive Resin Cement
2025-12-09 K252808 Shofu Dental Corporation GlasIonomer FX-LC
2025-10-28 K252165 Shofu Dental Corporation ZIRCONOMER P
2025-09-19 K250953 GC America, Inc. EQUIA LC ONE
2025-09-02 K251775 Belport Company, Inc., Gingi-Pak RODIN Cement
2025-07-11 K251470 Shofu Dental Corporation ResiCem EX
2025-07-11 K250156 Bisco, Inc. Choice 2 DC
2025-06-20 K250566 Spident Co., Ltd. EsCem RMGI
2025-01-10 K242366 Overfibers S.R.L. OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
2024-07-24 K240714 Cosmedent, Inc. Insure® Universal; Insure® Universal Automix
2024-06-28 K241204 Rizhao Huge Biomaterials Company, Ltd. TopCEM-Veneer Light Cure Veneer Cement
2024-04-02 K240888 Dentsply Sirona Calibra Abutment Resin Cement
2023-09-28 K233161 Shofu Dental Corporation BeautiLink SA
2023-07-28 K231552 DiaDent Group International Dia-Cem
2022-12-19 K214076 Spident Co., Ltd. EsCem
2022-09-22 K222253 Shofu Dental Corporation GlasIonomer FX ULTRA
2022-08-30 K214118 Sdi Limited Riva Cem Automix
2022-08-23 K220640 Voco GmbH Bifix Hybrid Abutment Cement