Cleared Special

K131451 - PALTOP DENTAL IMPLANT - STERILE ACCESSORIES

K131451 is an FDA 510(k) clearance for PALTOP DENTAL IMPLANT - STERILE ACCESSORIES, manufactured by Paltop Advanced Dental Solutions, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 94-day FDA review.

K131451 · Paltop Advanced Dental Solutions, Ltd. · Dental device
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Aug 2013
Decision
94d
Days
Class 2
Risk

K131451 is an FDA 510(k) clearance for the PALTOP DENTAL IMPLANT - STERILE ACCESSORIES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Paltop Advanced Dental Solutions, Ltd. (Caesarea, IL). The FDA issued a Cleared decision on August 22, 2013 after a review of 94 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Paltop Advanced Dental Solutions, Ltd. devices

FDA 510(k) Submission Details - K131451

510(k) Number K131451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date August 22, 2013
Days to Decision 94 days
Submission Type Special
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
34d faster than avg
Panel avg: 128d · This submission: 94d
Pathway characteristics
Modification to existing cleared device.

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 1371
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