EKI · Class I · 21 CFR 872.4565

FDA Product Code EKI: Carrier, Amalgam, Operative

Leading manufacturers include Premier Dental Products Co. and Buffalo Dental Mfg. Co., Inc..

2
Total
2
Cleared
44d
Avg days
1978
Since

FDA 510(k) Cleared Carrier, Amalgam, Operative Devices (Product Code EKI)

2 devices
1–2 of 2
Cleared Jan 11, 1995
AMALGAM CARRIER
K945220
Buffalo Dental Mfg. Co., Inc.
Dental · 77d
Cleared Jun 30, 1978
PREMIER INLAY PLACER
K781034
Premier Dental Products Co.
Dental · 11d

About Product Code EKI - Regulatory Context