Cleared Traditional

K990304 - MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM

K990304 is an FDA 510(k) clearance for MODIFICATION TO ASTRA TECH IMPLANT - DE..., manufactured by Astra Tech, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K990304 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
164d
Days
Class 2
Risk

K990304 is an FDA 510(k) clearance for the MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Lexington, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 164 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Astra Tech, Inc. devices

FDA 510(k) Submission Details - K990304

510(k) Number K990304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date July 15, 1999
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
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 1011
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K990304.
DYNA TORQ TORQUE WRENCH, TORQUE WRENCH
K991283 · Micro Motors, Inc. · Aug 1999
BICORTICAL SCREW
K983120 · Oraltronics Marketing-Und Vertriebs GmbH · Jul 1999
SYNOCTA PROSTHETICS
K990342 · Straumann USA · Jul 1999
REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM
K991114 · Lifecore Biomedical, Inc. · Jul 1999
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
K991053 · Astra Tech, Inc. · Jun 1999
SARGON IMMEDIATE LOAD IMPLANT, MODEL D
K981141 · Sargon Ent., Inc. · Jun 1999