Cleared Traditional

K910611 - NOBELPHARMA CERAONE ABUTMENT SYSTEM

K910611 is an FDA 510(k) clearance for NOBELPHARMA CERAONE ABUTMENT SYSTEM, 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 185-day FDA review.

K910611 · Nobelpharma USA, Inc. · Dental device
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Aug 1991
Decision
185d
Days
Class 2
Risk

K910611 is an FDA 510(k) clearance for the NOBELPHARMA CERAONE ABUTMENT 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 16, 1991 after a review of 185 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 Nobelpharma USA, Inc. devices

FDA 510(k) Submission Details - K910611

510(k) Number K910611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date August 16, 1991
Days to Decision 185 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
58d slower than avg
Panel avg: 127d · This submission: 185d
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 1264
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K910611.
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K911961 · Nobelpharma USA, Inc. · Jul 1991
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K903515 · Minimatic Implant Technology · Jul 1991
DEVICE PART NUMBERS: - 1400 SERIES
K911112 · Minimatic Implant Technology · Jun 1991