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FDA 510(k)

IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER

K-Number: K926305 · 1994-03-01

ApplicantThe Stern Metals Co., Inc.
Decision Date1994-03-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER is the device name listed in this FDA 510(k) record. The listed applicant is The Stern Metals Co., Inc.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K926305. 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 IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER?

IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is The Stern Metals Co., Inc.. The 510(k) number is K926305.

When did IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER receive FDA 510(k) clearance?

IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER received FDA 510(k) clearance on 1994-03-01, under 510(k) number K926305.

Who is the listed applicant for IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER?

The FDA 510(k) record lists The Stern Metals Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER?

The FDA product code for IMPLA-MED HEX SCREW IMPLANTS: 4,5 & 6MM DIAMETER is DZE.

Related Clinical Trials

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Other records listing The Stern Metals Co., Inc. 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.

K962301STERNGOLD G-HARD METAL ALLOYK933193IMPLA-MED UCLA TYPE ABUTMENTS,SCREWDRIVER,REAMER,LK924219ENDOSSEOUS IMPLANTS

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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