Cleared Traditional

K101732 - ASTRA TECH IMPLANT SYSTEM

K101732 is an FDA 510(k) clearance for ASTRA TECH IMPLANT SYSTEM, manufactured by Astra Tech AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K101732 · Astra Tech AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
247d
Days
Class 2
Risk

K101732 is an FDA 510(k) clearance for the ASTRA TECH IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech AB (San Diego, US). The FDA issued a Cleared decision on February 23, 2011 after a review of 247 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 Astra Tech AB devices

FDA 510(k) Submission Details - K101732

510(k) Number K101732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2010
Decision Date February 23, 2011
Days to Decision 247 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
120d slower than avg
Panel avg: 127d · This submission: 247d
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 1322
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101732.
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ET III SA ULTRA WIDE SYSTEM
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NEODENT IMPLANT SYSTEM
K101945 · Jjgc Industria E Comercio DE Materiais Dentarios S · Jan 2011
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K101225 · Promimic AB · Jan 2011
IMPLANT-ONE SYSTEM
K102822 · Custom Dental Implants, Inc. · Jan 2011