Cleared Traditional

K934827 - BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM

K934827 is an FDA 510(k) clearance for BRANEMARK SYSTEM ESTHETICONE NON-ROTATI..., manufactured by Nobelpharma USA, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K934827 · Nobelpharma USA, Inc. · Dental device
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Aug 1994
Decision
304d
Days
Class 2
Risk

K934827 is an FDA 510(k) clearance for the BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobelpharma USA, Inc. (Chicago, US). The FDA issued a Cleared decision on August 8, 1994 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K934827

510(k) Number K934827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1993
Decision Date August 08, 1994
Days to Decision 304 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
177d slower than avg
Panel avg: 127d · This submission: 304d
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 1265
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K934827.
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K931785 · Nobelpharma USA, Inc. · Aug 1994
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