Cleared Traditional

K901053 - MIRROR SHIELD

K901053 is the FDA 510(k) clearance for MIRROR SHIELD by Pulpdent Corp.. It is a Class 1 Dental device (product code EKJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K901053 · Pulpdent Corp. · Dental device
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May 1990
Decision
63d
Days
Class 1
Risk

K901053 is an FDA 510(k) clearance for the MIRROR SHIELD. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corp. devices

Submission Details

510(k) Number K901053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date May 07, 1990
Days to Decision 63 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKJ Burnisher, Operative

All 15
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K901053.
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · Degussa AG · Nov 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
RUBBER DAM CLAMPS/FORCEPS
K892261 · Zinnanti Surgical Instruments, Inc. · May 1989
PRICHARD PERIOSTEAL RETRACTOR #3
K892260 · Zinnanti Surgical Instruments, Inc. · May 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · Centrix, Inc. · Feb 1989