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FDA 510(k)

SYNTEC DENTAL IMPLANT

K-Number: K111189 · 2012-12-20

ApplicantSyntec Scientific Corp.
Decision Date2012-12-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTEC DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corp.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K111189. 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 SYNTEC DENTAL IMPLANT?

SYNTEC DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K111189.

When did SYNTEC DENTAL IMPLANT receive FDA 510(k) clearance?

SYNTEC DENTAL IMPLANT received FDA 510(k) clearance on 2012-12-20, under 510(k) number K111189.

Who is the listed applicant for SYNTEC DENTAL IMPLANT?

The FDA 510(k) record lists Syntec Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTEC DENTAL IMPLANT?

The FDA product code for SYNTEC DENTAL IMPLANT is DZE.

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Other records listing Syntec Scientific Corp. 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.

K101971SYNTEC OS SPINAL FIXATION SYSTEMK092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONK090476SYNTEC ORTHODONTIC MINI SCREWK090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSK984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEMK984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820

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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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