EMA · Class II · 21 CFR 872.3275

FDA Product Code EMA: Cement, Dental

FDA product code EMA covers dental cements used for the luting of restorations and the cementation of crowns, bridges, and orthodontic appliances.

These materials form a stable bond between tooth structure and restorative materials, sealing the margin against bacterial ingress and providing mechanical retention. Available formulations include resin, glass ionomer, zinc phosphate, and resin-modified glass ionomer cements.

EMA devices are Class II medical devices, regulated under 21 CFR 872.3275 and reviewed by the FDA Dental panel.

Leading manufacturers include Dentsply Intl., 3M Company and GC America, Inc..

505

Total

505

Cleared

98d

Avg days

1976

Since

Growing category - 15 submissions in the last 2 years vs 9 in the prior period

Review times increasing: avg 121d recently vs 97d historically

FDA 510(k) Cleared Cement, Dental Devices (Product Code EMA)

505 devices

1–24 of 505

1 2 3 4

REGEN Bioactive Cement

Bifix Veneer LC, Bifix Veneer Try-In

TopCEM Vigor SA Self-Adhesive Resin Cement

K252785

Rizhao Huge Biomaterials Company, Ltd.

Shofu Dental Corporation

Shofu Dental Corporation

Belport Company, Inc., Gingi-Pak

Shofu Dental Corporation

TopCEM-Veneer Light Cure Veneer Cement

K241204

Rizhao Huge Biomaterials Company, Ltd.

Dental · 59d

Cleared Apr 02, 2024

Calibra Abutment Resin Cement

Shofu Dental Corporation

DiaDent Group International

Shofu Dental Corporation

Bifix Hybrid Abutment Cement

NOVA RESIN dual cure, self adhesive resin cement

K213609

Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

Dental · 267d

Cleared Jun 01, 2022

DeltaFil, DeltaFil Conditioner

K213201

Dmg Chemisch Pharmazeutische Fabrik GmbH

Dental · 245d

1 2 3 4

About Product Code EMA - Regulatory Context

510(k) Submission Activity

505 total 510(k) submissions under product code EMA since 1976, with 505 receiving FDA clearance (average review time: 98 days).

Submission volume has increased in recent years - 15 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EMA Product Code

Recent submissions under EMA have taken an average of 121 days to reach a decision - up from 97 days historically. Manufacturers should account for longer review timelines in current project planning.

EMA devices are reviewed by the Dental panel. Browse all Dental devices →

FDA Product Code EMA: Cement, Dental

FDA 510(k) Cleared Cement, Dental Devices (Product Code EMA)

About Product Code EMA - Regulatory Context

510(k) Submission Activity

FDA 510(k) Review Time - EMA Product Code

Related FDA 510(k) Regulatory Insights