Home / 510(k) Clearances / K850927

510(k) K850927

COMPLETE DENTURE REPAIR KIT by Tooth Aid Lab, Inc. — Product Code EBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1985
Date Received
March 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Denture Repair Kit
Device Class
Class II
Regulation Number
872.3570
Review Panel
DE
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances for product code EBO

  • K844480 — DENTAL ORAL CARE SYSTEMS & COMPONENTS (June 19, 1985)
  • K833057 — UNIVERSAL FIX-A-PLATE (February 27, 1984)
  • K833056 — UNIVERSAL LINE-A-PLATE (February 27, 1984)
  • K820245 — SAFE TDENT (April 9, 1982)
  • K820685 — DENTURE ADJUSTMENT KIT (April 9, 1982)
  • K770091 — EMERGENCY FAST-FIX DENTURE REPAIR KIT (January 24, 1977)