Cleared Traditional

K980442 - CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM

K980442 is an FDA 510(k) clearance for CRYSTAL AND CRYSTAL-SEAL 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 40-day FDA review.

K980442 · Crystal Medical Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
40d
Days
Class 2
Risk

K980442 is an FDA 510(k) clearance for the CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Crystal Medical Technology (Pelham, US). The FDA issued a Cleared decision on March 16, 1998 after a review of 40 days - a notably fast clearance cycle.

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: 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 Crystal Medical Technology devices

FDA 510(k) Submission Details - K980442

510(k) Number K980442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1998
Decision Date March 16, 1998
Days to Decision 40 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 127d · This submission: 40d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K980442.
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K974856 · Vancouver Implant Resources, Inc. · Feb 1998