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510(k) K760620

SALIVA EJECTOR by Lorvic Corp. — Product Code DYN

K760620 is an FDA 510(k) premarket notification submitted by Lorvic Corp. for the device "SALIVA EJECTOR". The FDA issued a decision of Substantially Equivalent on September 21, 1976. The device falls under product code DYN (Mouthpiece, Saliva Ejector), a Class I device regulated under 21 CFR 872.6640. Lorvic Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1976
Date Received
September 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Saliva Ejector
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Lorvic Corp.

  • K871615 — U. V. GERMICIDAL UNIT (September 11, 1987)
  • K780263 — SHIELD (May 3, 1978)
  • K770064 — FLUORIDE GEL DISPOSABLE TRAY (January 14, 1977)
  • K770063 — DISP. ABSORBENT COMPRESSED FIBRE WAFER (January 14, 1977)
  • K760121 — IMPULSE HEAT SEALER (July 16, 1976)

Other clearances for product code DYN

  • K940769 — DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (August 17, 1994)
  • K935758 — HYGOFLEX SALIVA-EJECTOR (March 21, 1994)
  • K935616 — SALIVA EJECTOR DISPOSABLE (March 21, 1994)
  • K924211 — EJECTOR (March 31, 1993)
  • K920492 — HIGH VAC (May 11, 1992)
  • K921117 — MINIDAM (May 5, 1992)
  • K900631 — SALIVA ABSORBER - DENTAL (April 4, 1990)
  • K871315 — ORAL ASPIRATOR (April 15, 1987)
  • K870599 — TIP, DENTAL SUCTION APPARATUS (March 23, 1987)
  • K864300 — SILIVA EJECTOR/ORAL CAVITY EVACUATOR (November 24, 1986)

FDA data resources