510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K837491Substantially Equivalent

Rex Pedestal Intra-Oral X-Ray Unit

The Yoshida Dental Mfg. Co., Ltd., Tokyo, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837491 is the FDA 510(k) clearance record for REX PEDESTAL INTRA-ORAL X-RAY UNIT, cleared for The Yoshida Dental Mfg. Co., Ltd. on . FDA records list 9 510(k) clearances for The Yoshida Dental Mfg. Co., Ltd., from to . As of , FDA records show no recalls naming K837491.

Clearance record

Decision date
Received
(74 days to decision)
Review panel
Unknown
Applicant
The Yoshida Dental Mfg. Co., Ltd. 1-3-6, Kotobashi, Sumida-Ku, Tokyo, JP
Third party review
No