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510(k) K811582

THE PLACER by Cavitron Corp. — Product Code EID

K811582 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "THE PLACER". The FDA issued a decision of Substantially Equivalent on July 28, 1981. The device falls under product code EID (Syringe, Restorative And Impression Material), a Class I device regulated under 21 CFR 872.4565. Cavitron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1981
Date Received
June 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Restorative And Impression Material
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Cavitron Corp.

  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)
  • K802928 — SPIROMETRIC COMPUTER #SC-10 (December 17, 1980)
  • K801623 — CAVITRON ULTRASONIC SURG. ASPIR. CUSA (November 18, 1980)
  • K801877 — SLIT LAMP ATTACHMENT (September 16, 1980)
  • K800869 — MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (May 28, 1980)
  • K800722 — AUTO-FIELD D AUTOMATED VISUAL DETECTOR (April 29, 1980)
  • K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT (September 19, 1979)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)
  • K782065 — LASER, PHOTOCOAGULATION (December 28, 1978)

Other clearances for product code EID

  • K941431 — BONE GRAFT DELIVERY SYRINGES (July 12, 1994)
  • K913974 — ACCESS IMPRESSION BARREL (February 25, 1992)
  • K873153 — CAULK'S VPS CARTRIDGE SYSTEM (September 16, 1987)
  • K871937 — IMPRESSION SYRINGE (June 5, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812680 — G-C IMPRESSION SYRINGE (October 6, 1981)
  • K812277 — PRISMA-FIL COMPULES (September 8, 1981)
  • K781977 — APPLICATOR, LEE IMPRESSION (December 20, 1978)

FDA data resources