Atlas FDA

REX PEDESTAL INTRA-ORAL X-RAY UNIT

FDA 510(k) clearance K837491 · decided 1983-06-13

Clearance details

K-number
K837491
Device name
REX PEDESTAL INTRA-ORAL X-RAY UNIT
Applicant
The Yoshida Dental Mfg. Co., Ltd.
Decision
Substantially Equivalent
Date received
1983-03-31
Decision date
1983-06-13
Days to decision
74 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Tokyo, JP
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch The Yoshida Dental Mfg. Co.

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Recalls involving this device

No recalls on record reference this clearance.