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510(k) K830775

FACEBOW FOR BALANCE ARTICULATOR by Almore Intl., Inc. — Product Code KCR

K830775 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "FACEBOW FOR BALANCE ARTICULATOR". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code KCR (Facebow), a Class I device regulated under 21 CFR 872.3220. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
March 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Facebow
Device Class
Class I
Regulation Number
872.3220
Review Panel
DE
Submission Type

Other clearances by Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)

FDA data resources