Cleared Traditional

K100512 - NOBELPROCERA IPS E.MAX CROWN

K100512 is an FDA 510(k) clearance for NOBELPROCERA IPS E.MAX CROWN, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K100512 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
179d
Days
Class 2
Risk

K100512 is an FDA 510(k) clearance for the NOBELPROCERA IPS E.MAX CROWN. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on August 20, 2010 after a review of 179 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 - K100512

510(k) Number K100512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date August 20, 2010
Days to Decision 179 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
51d slower than avg
Panel avg: 128d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 482
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K100512.
HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
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K102538 · Jyoti Ceramic Industries Private Limited · Oct 2010
BK BLANK MODEL 20,40,65,90
K101875 · Bk Medent Co., Ltd. · Aug 2010
VITABLOCS
K102128 · Vita Zahnfabrik H.Rauter GmbH & Co. · Aug 2010
OBSIDIAN CERAMIC BLOCKS
K100781 · Prismatik Dentalcraft, Inc. · Jun 2010
CERAMICS2IN1
K100150 · Biodenta Swiss AG · May 2010
K100512 · NOBELPROCERA IPS E.MAX CROWN
Download PDF FDA Summary Nobel Biocare AB