Cleared Traditional

K981858 - ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT...

K981858 is an FDA 510(k) clearance for ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT..., manufactured by Atlantis Components, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K981858 · Atlantis Components, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
299d
Days
Class 2
Risk

K981858 is an FDA 510(k) clearance for the ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREW. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Atlantis Components, Inc. (Cambridge, US). The FDA issued a Cleared decision on March 22, 1999 after a review of 299 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 Atlantis Components, Inc. devices

FDA 510(k) Submission Details - K981858

510(k) Number K981858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1998
Decision Date March 22, 1999
Days to Decision 299 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
172d slower than avg
Panel avg: 127d · This submission: 299d
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 839
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K981858.
PDQ AND PDQ-TI ABUTMENT
K990367 · Vident · Apr 1999
MODIFICATION TO IMTEC SENDAX MDI
K990983 · Imtec Corp. · Apr 1999
O-RING ABUTMENT
K990277 · BioHorizons Implant Systems, Inc. · Apr 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · Institut Straumann AG · Mar 1999
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · Nobel Biocare Uas, Inc. · Mar 1999
WIDE BODY ABUTMENTS
K984198 · Vident · Feb 1999