Cleared Traditional

K925312 - HAND INSTRUMENT CALCULUS REMOVAL

K925312 is an FDA 510(k) clearance for HAND INSTRUMENT CALCULUS REMOVAL, manufactured by Implant Support Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 579-day FDA review.

K925312 · Implant Support Systems, Inc. · Dental device
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May 1994
Decision
579d
Days
Class 2
Risk

K925312 is an FDA 510(k) clearance for the HAND INSTRUMENT CALCULUS REMOVAL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Support Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on May 23, 1994 after a review of 579 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Implant Support Systems, Inc. devices

FDA 510(k) Submission Details - K925312

510(k) Number K925312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1992
Decision Date May 23, 1994
Days to Decision 579 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
452d slower than avg
Panel avg: 127d · This submission: 579d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1319
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K925312.
SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K941554 · Lifecore Biomedical, Inc. · Jul 1994
RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM
K931468 · Lifecore Biomedical, Inc. · Jul 1994
IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM
K932123 · Implant Innovations International, Inc. · May 1994
BRANEMARK SYST. HAND INST. DIA 297 & SDIA 276
K925483 · Nobelpharma USA, Inc. · May 1994
TAPERED ABUTMENT AND RELATED COMPONENTS
K933969 · Implant Innovations, Inc. · Apr 1994
ONE AND TWO PIECE TEMPORARY HEALING,(EMERGENCE PROFILE) ABUTMENTS
K934126 · Implant Innovations, Inc. · Apr 1994