Cleared Traditional

K994119 - SYNOCTA ANGLED ABUTMENTS

K994119 is an FDA 510(k) clearance for SYNOCTA ANGLED ABUTMENTS, manufactured by Straumann USA. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K994119 · Straumann USA · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
102d
Days
Class 2
Risk

K994119 is an FDA 510(k) clearance for the SYNOCTA ANGLED ABUTMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA (Waltham, US). The FDA issued a Cleared decision on March 17, 2000 after a review of 102 days - within the typical 510(k) review window.

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 Straumann USA devices

FDA 510(k) Submission Details - K994119

510(k) Number K994119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date March 17, 2000
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
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 1242
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K994119.
BRANEMARK NOVUM
K000018 · Nobel Biocare Uas, Inc. · Mar 2000
UCLA/UNIVERSAL ABUTMENT
K993129 · Diamodent · Mar 2000
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING
K994376 · Friadent GmbH · Mar 2000
LOCATOR IMPLANT ANCHOR
K994257 · Zest Anchors, Inc. · Mar 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000