Cleared Traditional

K911281 - PULPDENT PIC N STIC

K911281 is an FDA 510(k) clearance for PULPDENT PIC N STIC, manufactured by Pulpdent Corp.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K911281 · Pulpdent Corp. · Dental device
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May 1991
Decision
57d
Days
Class 1
Risk

K911281 is an FDA 510(k) clearance for the PULPDENT PIC N STIC. 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 15, 1991 after a review of 57 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.

FDA 510(k) Submission Details - K911281

510(k) Number K911281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date May 15, 1991
Days to Decision 57 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
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

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 71
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K911281.
ACCU-PLACER TM KIT
K912473 · Hu-Friedy Mfg. Co., Inc. · Jul 1991
NUTIP (TM) SYRINGE SHIELD
K911214 · Western M/D, Inc. · Jul 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990
AMALGAM CONDENSER
K901178 · American Medical Ceramics, Inc. · Apr 1990
5 STRAIGHT SCISSORS
K901169 · American Medical Ceramics, Inc. · Apr 1990
K911281 · PULPDENT PIC N STIC
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