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510(k) K944162

DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM by Teledyne Water Pik — Product Code EAG

K944162 is an FDA 510(k) premarket notification submitted by Teledyne Water Pik for the device "DENAR ACCUCEPH CEPHALOMETER IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 29, 1994. The device falls under product code EAG (Cephalometer), a Class II device regulated under 21 CFR 872.1830. Teledyne Water Pik has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1994
Date Received
August 26, 1994
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 by Teledyne Water Pik

  • K970594 — KALGINATE IMPRESSION MATERIAL (March 31, 1997)
  • K952422 — ELASTIC IMPRESSION CREAM (August 29, 1995)
  • K940288 — WATER PIK SENSONIC PLAQUE REMOVAL INSTRUMENT (May 26, 1994)
  • K931380 — WATER PIK PLUS PLAQUE CONTROL SYSTEM (September 20, 1993)
  • K905188 — PERIO PIK (February 15, 1991)
  • K900547 — WATER PIK(R) W/ADD'L CLAIMS (June 15, 1990)
  • K895259 — PIK POCKET(R), MODEL PP-3 (November 1, 1989)
  • K894015 — WATER PIK(R) (August 28, 1989)

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)
  • 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)
  • K810538 — PLASTICEPH (April 29, 1981)
  • K781287 — DENTAL X-RAY UNIT W/CEPHALOMETRIC ATTACH (September 11, 1978)

FDA data resources