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510(k) K101771

RELINE-IT MODEL RELINE-IT by Majestic Drug Co., Inc. — Product Code EBP

K101771 is an FDA 510(k) premarket notification submitted by Majestic Drug Co., Inc. for the device "RELINE-IT MODEL RELINE-IT". The FDA issued a decision of Substantially Equivalent on September 20, 2010. The device falls under product code EBP (Reliner, Denture, Over The Counter), a Class II device regulated under 21 CFR 872.3560. Majestic Drug Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2010
Date Received
June 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reliner, Denture, Over The Counter
Device Class
Class II
Regulation Number
872.3560
Review Panel
DE
Submission Type

Other clearances by Majestic Drug Co., Inc.

  • K964773 — DENTEMP ONE STEP (February 21, 1997)
  • K821581 — DEN TEMP (June 14, 1982)

Other clearances for product code EBP

  • K121318 — PROSOFT (June 6, 2012)
  • K790589 — DENTURE-TIGHT (August 10, 1979)

FDA data resources