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510(k) K810538

PLASTICEPH by Morningstar Dental Co. — Product Code EAG

K810538 is an FDA 510(k) premarket notification submitted by Morningstar Dental Co. for the device "PLASTICEPH". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
February 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cephalometer
Device Class
Class II
Regulation Number
872.1830
Review Panel
RA
Submission Type

Other clearances for product code EAG

  • K030699 — VERAVIEWEPOCS PANORAMIC/CEPHALOMETRIC X-RAY UNIT WITH CEPHALOMETRIC (May 29, 2003)
  • K021372 — VERAVIEWEPOCS PANORAMIC X-RAY UNIT WITH CEPHALOMETRIC CAPABILITY (June 7, 2002)
  • K944162 — DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM (November 29, 1994)
  • K920189 — GX-C CEPHALOMETER (April 28, 1992)
  • K896099 — DIGIGRAPH DIAGNOSTIC WORK/STATION (January 31, 1991)
  • K870243 — BURNETT TMJ APPLIANCE (February 24, 1987)
  • K842463 — GX CEPH (August 2, 1984)
  • K833006 — CEPHALOMETER & FIXATOR (January 3, 1984)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)

FDA data resources