Cleared Traditional

K894595 - BONEFIT R SCREW IMPLANTS

K894595 is an FDA 510(k) clearance for BONEFIT R SCREW IMPLANTS, manufactured by Institut Straumann AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K894595 · Institut Straumann AG · Dental device
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Feb 1990
Decision
204d
Days
Class 2
Risk

K894595 is an FDA 510(k) clearance for the BONEFIT R SCREW IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Walenburg, CH). The FDA issued a Cleared decision on February 13, 1990 after a review of 204 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.

FDA 510(k) Submission Details - K894595

510(k) Number K894595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date February 13, 1990
Days to Decision 204 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 128d · This submission: 204d
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 1548
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K894595.
OSSEODENT(R) PRECISION DENTAL ATTACHMENTS
K895463 · Collagen Corp. · Mar 1990
BONEFIT HOLLOW CYLINDER IMPLANTS
K894593 · Institut Straumann AG · Feb 1990
BONEFIT HOLLOW SCREW IMPLANTS
K894594 · Institut Straumann AG · Feb 1990
BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
K894844 · Straumann Institute, Ltd. · Feb 1990
ARTECH TYPE SS SUBMERGED SCREW IMPLANT
K891346 · Artech Corp. · Dec 1989
OSSEODENT PROSTHETIC KIT
K895333 · Celtrix Laboratories · Nov 1989
K894595 · BONEFIT R SCREW IMPLANTS
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