Cleared Traditional

K933646 - CAL-FORM DENTAL IMPLANTS

K933646 is an FDA 510(k) clearance for CAL-FORM DENTAL IMPLANTS, manufactured by Cal-Form, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 891-day FDA review.

K933646 · Cal-Form, Inc. · Dental device
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Jan 1996
Decision
891d
Days
Class 2
Risk

K933646 is an FDA 510(k) clearance for the CAL-FORM DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cal-Form, Inc. (Longwood, US). The FDA issued a Cleared decision on January 4, 1996 after a review of 891 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 Cal-Form, Inc. devices

FDA 510(k) Submission Details - K933646

510(k) Number K933646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date January 04, 1996
Days to Decision 891 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
764d slower than avg
Panel avg: 127d · This submission: 891d
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 1246
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K933646.
RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM
K954819 · Lifecore Biomedical, Inc. · Jan 1996
RESTORE HA DENTAL IMPLANT SYSTEM
K954865 · Lifecore Biomedical, Inc. · Jan 1996
KIS MED THREAD IMPLANT & PROSTHESIS SYSTEM
K955048 · The Implant Center of the Palm Beaches · Jan 1996
INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946319 · Calcitek, Inc. · Nov 1995
INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM
K946345 · Calcitek, Inc. · Nov 1995
WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SS
K952985 · Implant Center of the Palm Beaches · Oct 1995