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FDA 510(k)

SPIRAL LOCK DENTAL IMPLANT SYSTEM

K-Number: K925796 · 1994-05-23

ApplicantRobert A James
Decision Date1994-05-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPIRAL LOCK DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Robert A James. It received FDA 510(k) clearance on 1994-05-23 under 510(k) number K925796. 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 SPIRAL LOCK DENTAL IMPLANT SYSTEM?

SPIRAL LOCK DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Robert A James. The 510(k) number is K925796.

When did SPIRAL LOCK DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

SPIRAL LOCK DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1994-05-23, under 510(k) number K925796.

Who is the listed applicant for SPIRAL LOCK DENTAL IMPLANT SYSTEM?

The FDA 510(k) record lists Robert A James as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRAL LOCK DENTAL IMPLANT SYSTEM?

The FDA product code for SPIRAL LOCK DENTAL IMPLANT SYSTEM is DZE.

Related Clinical Trials

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.

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Other records listing Robert A James 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.

K926100SPIRAL LOCK DENTAL IMPLANT SYSTEM

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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