Home / 510(k) Clearances / K830439

510(k) K830439

DENTA A-33 by Denta, Inc. — Product Code EGG

K830439 is an FDA 510(k) premarket notification submitted by Denta, Inc. for the device "DENTA A-33". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Denta, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
February 10, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type

Other clearances by Denta, Inc.

  • K830440 — DENTA PLAST (April 28, 1983)

Other clearances for product code EGG

  • K990979 — STECO-TITANMAGNETICS (September 3, 1999)
  • K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS (December 6, 1996)
  • K925700 — ZEST ANCHOR ADVANCED GENERATION (April 7, 1994)
  • K915299 — COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (January 31, 1992)
  • K912435 — DENTAL CONNECTOR PRECISION ATTACHMENT (August 28, 1991)
  • K912567 — CONICAST, INTRACAST, OMECAST (July 2, 1991)
  • K901928 — INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH (July 26, 1990)
  • K900785 — MICRO 2 SYSTEM (April 16, 1990)
  • K896337 — DENTAL BRIDGE ANCHORING PINS (January 31, 1990)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)

FDA data resources