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510(k) K837491

REX PEDESTAL INTRA-ORAL X-RAY UNIT by The Yoshida Dental Mfg. Co., Ltd.

K837491 is an FDA 510(k) premarket notification submitted by The Yoshida Dental Mfg. Co., Ltd. for the device "REX PEDESTAL INTRA-ORAL X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on Jun 13, 1983. The Yoshida Dental Mfg. Co., Ltd. has 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 13, 1983
Date Received
Mar 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by The Yoshida Dental Mfg. Co., Ltd.

  • K182198 — Panoura X-ERA PF/NF/MF (Jan 31, 2019)
  • K122199 — PREXION3D ECLIPSE (Apr 18, 2013)
  • K120948 — PREXION 3D (Dec 21, 2012)
  • K120932 — OPELASER PRO II AND THE OPELASER LITE II (Dec 7, 2012)
  • K111231 — PANOURA 18S (Jul 13, 2011)
  • K063622 — FINECUBE DENTAL CT (Feb 8, 2007)
  • K000577 — YOSHIDA WAVE PICT CAM INTRAORAL CAMERA, SIGMA BIOMEDICS SIGMACAM INTRAORAL… (May 5, 2000)
  • K828325 — YOSHIDA/KAYCOR X-70 X-RAY UNIT (Oct 21, 1982)

FDA data resources