Cleared Traditional

K872089 - APACERAM HYDROXYLAPATITE DENTAL IMPLANT...

K872089 is the FDA 510(k) clearance for APACERAM HYDROXYLAPATITE DENTAL IMPLANT... by Asahi Optical Co. C/O Rosati Associates, P.C.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K872089 · Asahi Optical Co. C/O Rosati Associates, P.C. · Dental device
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Aug 1987
Decision
74d
Days
Class 2
Risk

K872089 is an FDA 510(k) clearance for the APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Asahi Optical Co. C/O Rosati Associates, P.C. (West Bloomfield, US). The FDA issued a Cleared decision on August 14, 1987 after a review of 74 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 Asahi Optical Co. C/O Rosati Associates, P.C. devices

Submission Details

510(k) Number K872089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1987
Decision Date August 14, 1987
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 653
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K872089.
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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