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FDA 510(k)

PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT

K-Number: K130462 · 2013-08-27

ApplicantPaltop Advanced Dental Solutions, Ltd.
Decision Date2013-08-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2013-08-27 under 510(k) number K130462. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT?

PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT is a medical device that received FDA 510(k) clearance on 2013-08-27. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K130462.

When did PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT receive FDA 510(k) clearance?

PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT received FDA 510(k) clearance on 2013-08-27, under 510(k) number K130462.

Who is the listed applicant for PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT?

The FDA 510(k) record lists Paltop Advanced Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT?

The FDA product code for PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT is DZE.

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Other records listing Paltop Advanced Dental Solutions, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243983Paltop Dental Implant SystemK232740Paltop Short ImplantsK220200Paltop Conical Implant SystemK210117Paltop Narrow ImplantK131451PALTOP DENTAL IMPLANT - STERILE ACCESSORIESK112795PALTOP DENTAL IMPLANT SYSTEM

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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