Cleared Traditional

K895985 - SANI-PIKS DENTAL HAND INSTRUMENT

K895985 is an FDA 510(k) clearance for SANI-PIKS DENTAL HAND INSTRUMENT, manufactured by Bison-Lee Co.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895985 · Bison-Lee Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
89d
Days
Class 1
Risk

K895985 is an FDA 510(k) clearance for the SANI-PIKS DENTAL HAND INSTRUMENT. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Bison-Lee Co. (Tempe, US). The FDA issued a Cleared decision on January 10, 1990 after a review of 89 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 Bison-Lee Co. devices

FDA 510(k) Submission Details - K895985

510(k) Number K895985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1989
Decision Date January 10, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 127d · This submission: 89d
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 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K895985.
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991
PULPDENT PIC N STIC
K911281 · Pulpdent Corp. · May 1991
MIRROR SHIELD
K901053 · Pulpdent Corp. · May 1990
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