Cleared Traditional

K894844 - BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS

K894844 is an FDA 510(k) clearance for BONEFIT IMPLANT SYSTEM ACCESSORIES & IN..., manufactured by Straumann Institute, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K894844 · Straumann Institute, Ltd. · Dental device
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Feb 1990
Decision
186d
Days
Class 2
Risk

K894844 is an FDA 510(k) clearance for the BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann Institute, Ltd. (Brookline, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 186 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 Straumann Institute, Ltd. devices

FDA 510(k) Submission Details - K894844

510(k) Number K894844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date February 02, 1990
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
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 1329
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K894844.
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
OVERDENTURE ATTACHMENT
K891613 · Implant Innovations International, Inc. · Oct 1989
BIO-VENT
K883717 · Core-Vent Corp. · Sep 1989
O BUTMENT
K884296 · "O" Co., Inc. · Aug 1989