Cleared Traditional

K210097 - Estar-Z

K210097 is the FDA 510(k) clearance for Estar-Z by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K210097 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
169d
Days
Class 2
Risk

K210097 is an FDA 510(k) clearance for the Estar-Z. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on July 2, 2021 after a review of 169 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.

View all Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K210097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2021
Decision Date July 02, 2021
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Hiossen, Inc.
Peter Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K210097.
Amber Mill Q Series & Amber Mill Direct Series
K202952 · Hass Corp. · Aug 2021
IPS e.max One
K211916 · Ivoclar Vivadent, AG · Aug 2021
1Derful HS, 1Derful HT
K210884 · 1derful, Inc. · Jul 2021
MAZIC Claro CAD and MAZIC Claro Press
K203672 · Vericom Co., Ltd. · Jul 2021
Perfit FS Dental Zirconia Fully Sintered Block
K203590 · Vatech Acucera, Inc. · Jun 2021
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
K203499 · Vatech Acucera, Inc. · Apr 2021