Cleared Traditional

K081900 - TEMPORARY TOOTH REPLACEMENT

K081900 is an FDA 510(k) clearance for TEMPORARY TOOTH REPLACEMENT, manufactured by Ormco Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K081900 · Ormco Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
113d
Days
Class 2
Risk

K081900 is an FDA 510(k) clearance for the TEMPORARY TOOTH REPLACEMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on October 24, 2008 after a review of 113 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 Ormco Corp. devices

FDA 510(k) Submission Details - K081900

510(k) Number K081900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date October 24, 2008
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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 938
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081900.
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · BioHorizons Implant Systems, Inc. · Nov 2008
MOLAR IMPLANT
K081128 · Nobel Biocare AB · Nov 2008
GS III FIXTURE SYSTEM
K082213 · Osstem Implant Co., Ltd. · Oct 2008
MDI MII ONE-PIECE IMPLANT, 2.9MM
K081653 · Imtec Corp. · Sep 2008
MS SYSTEM (NARROW RIDGE)
K080594 · Osstem Implant Co., Ltd. · Sep 2008