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FDA 510(k)

POSI-STOP/POSI-TRAC SYSTEM

K-Number: K981997 · 1999-01-12

ApplicantThe Dental Medical Device Co., LLC
Decision Date1999-01-12
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POSI-STOP/POSI-TRAC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Dental Medical Device Co., LLC. It received FDA 510(k) clearance on 1999-01-12 under 510(k) number K981997. 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 POSI-STOP/POSI-TRAC SYSTEM?

POSI-STOP/POSI-TRAC SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-12. The listed applicant is The Dental Medical Device Co., LLC. The 510(k) number is K981997.

When did POSI-STOP/POSI-TRAC SYSTEM receive FDA 510(k) clearance?

POSI-STOP/POSI-TRAC SYSTEM received FDA 510(k) clearance on 1999-01-12, under 510(k) number K981997.

Who is the listed applicant for POSI-STOP/POSI-TRAC SYSTEM?

The FDA 510(k) record lists The Dental Medical Device Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POSI-STOP/POSI-TRAC SYSTEM?

The FDA product code for POSI-STOP/POSI-TRAC SYSTEM is DZE.

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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

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

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