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510(k) K837382

OPTISON ULTRASONIC SCALER by Pelton & Crane Co.

K837382 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "OPTISON ULTRASONIC SCALER". The FDA issued a decision of Substantially Equivalent on May 6, 1983. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1983
Date Received
March 4, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Pelton & Crane Co.

  • K171872 — P50 Series Dental Operative Unit and Accessories (April 26, 2018)
  • K143696 — Spirit (September 18, 2015)
  • K972249 — ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD (September 12, 1997)
  • K972168 — SIDEXIS DIGITAL RADIOGRAPHY SYSTEM (September 5, 1997)
  • K945117 — DELTA (February 28, 1997)
  • K962071 — SPIRIT S1/S2 (August 6, 1996)
  • K960819 — HELIODENT DS (March 29, 1996)
  • K950299 — CEREC 2 (May 23, 1995)
  • K946187 — SPIRIT II AND SPIRIT TREATMENT CENTER (March 1, 1995)
  • K950030 — HELIODENT MD (February 3, 1995)

FDA data resources