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510(k) K110768

COMPUTED DENTAL RADIOGRAPHY by Schick Technologies, Inc. — Product Code MUH

K110768 is an FDA 510(k) premarket notification submitted by Schick Technologies, Inc. for the device "COMPUTED DENTAL RADIOGRAPHY". The FDA issued a decision of Substantially Equivalent on April 20, 2011. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Schick Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2011
Date Received
March 18, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

Other clearances by Schick Technologies, Inc.

  • K093453 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (November 30, 2009)
  • K072134 — SCHICK COMPUTED ORAL RADIOLOGY SYSTEM (November 2, 2007)
  • K053558 — CEPH, MODEL 4900 (February 17, 2006)
  • K041385 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (June 7, 2004)
  • K031291 — CDR PANX, MODEL 4792 (May 5, 2003)
  • K022953 — MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM (October 2, 2002)
  • K001429 — MODIFICATION TO ACCUDEXA BONE DENSITOMETER (May 26, 2000)
  • K982661 — CDR - PAN MODEL 4700 (December 11, 1998)
  • K981124 — ACCUDEXA BONE DENSITOMETER (June 4, 1998)
  • K971735 — ACCUDEXA BONE DENSITOMETER (December 2, 1997)

Other clearances for product code MUH

  • K251793 — SOTA Cloud Smart Sensor (1.5) (March 3, 2026)
  • K252570 — EzSensor HD, EzSensor UHD (November 10, 2025)
  • K250687 — Cocoon Solo (DX-7020s) (October 24, 2025)
  • K251206 — Digital X-Ray DentiMax Pro Imaging System (September 24, 2025)
  • K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta (October 25, 2024)
  • K242778 — X Sensor (Model: IOS-A15IF, HDI-15DGF) (October 11, 2024)
  • K241649 — DUO1 and DUO2 (July 5, 2024)
  • K232325 — RAYSCAN a-Expert (April 18, 2024)
  • K231660 — Digital image scanner of dental (December 20, 2023)
  • K233053 — DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 (November 21, 2023)

FDA data resources