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510(k) K890290

BRACE (ORAFIX SPECIAL) by Norcliff Thayer, Inc. — Product Code ECB

K890290 is an FDA 510(k) premarket notification submitted by Norcliff Thayer, Inc. for the device "BRACE (ORAFIX SPECIAL)". The FDA issued a decision of Substantially Equivalent on March 29, 1989. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Norcliff Thayer, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
January 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Norcliff Thayer, Inc.

  • K791576 — FORGET - DENTURE BONDING LIQUID (October 26, 1979)
  • K780174 — ORABRITE (February 23, 1978)
  • K771002 — ICE BAND (August 30, 1977)

Other clearances for product code ECB

  • K942519 — UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (August 23, 1994)
  • K931772 — SURETIP SYRINGE TIP COVER (March 7, 1994)
  • K931137 — DENTAL SYRINGE TIP (November 29, 1993)
  • K923876 — RISKONTROL SINGLE USE (April 5, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 1992)
  • K920499 — SANI-TIP (May 3, 1992)
  • K911756 — POSTERIOR NASAL EPISTAXIS INSTRUMENTS (October 24, 1991)
  • K863024 — SERINGA TRIPLICE S.L. (September 25, 1986)
  • K854699 — TUBING SYRING (January 6, 1986)
  • K801686 — SPACELINE THREE WAY SYRINGE (August 4, 1980)

FDA data resources