Cleared Traditional

K882578 - ASTRA DENTAL IMPLANT SYSTEM

K882578 is an FDA 510(k) clearance for ASTRA DENTAL IMPLANT SYSTEM, manufactured by Astra Meditec AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K882578 · Astra Meditec AB · Dental device
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Aug 1988
Decision
51d
Days
Class 2
Risk

K882578 is an FDA 510(k) clearance for the ASTRA DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Meditec AB (Sweden, SE). The FDA issued a Cleared decision on August 12, 1988 after a review of 51 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 Astra Meditec AB devices

FDA 510(k) Submission Details - K882578

510(k) Number K882578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1988
Decision Date August 12, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
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 700
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K882578.
BONEFIT HOLLOW CYLINDER IMPLANTS
K894593 · Institut Straumann AG · Feb 1990
BONEFIT HOLLOW SCREW IMPLANTS
K894594 · Institut Straumann AG · Feb 1990
BONEFIT R SCREW IMPLANTS
K894595 · Institut Straumann AG · Feb 1990
TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT
K871219 · Depuy, Inc. · Jun 1987
MONOJECT ENDOSSEOUS DENTAL IMPLANT
K781060 · Sherwood Medical Industries · Aug 1978