Cleared Traditional

K954432 - CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM

K954432 is an FDA 510(k) clearance for CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM, manufactured by Crystal Medical Technology. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K954432 · Crystal Medical Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
303d
Days
Class 2
Risk

K954432 is an FDA 510(k) clearance for the CRYSTAL & CRYSTAL-PLUS IMPLANTS SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Crystal Medical Technology (Birmingham, US). The FDA issued a Cleared decision on July 24, 1996 after a review of 303 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Crystal Medical Technology devices

FDA 510(k) Submission Details - K954432

510(k) Number K954432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date July 24, 1996
Days to Decision 303 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 127d · This submission: 303d
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 941
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954432.
STERI-OSS APICAL IMPLANT
K960398 · Steri-Oss, Inc. · Aug 1996
3I STND THREADED/SELF TAPPING THREADED/3I MINIPLANT IMPLANTS/3 I EMERGENCE PROF. TEMP. HEALING ABUTMENTS
K960417 · Implant Innovations, Inc. · Aug 1996
STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
K960886 · Steri-Oss, Inc. · Aug 1996
BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE
K962130 · Nobelpharma USA, Inc. · Jul 1996
CERA ONE ABUTMENT SYSTEM
K961737 · Nobelpharma USA, Inc. · Jul 1996
ACE SREW DENTLA IMPLANT SYSTEM
K954513 · Ace Surgical Supply Co., Inc. · Jun 1996