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FDA 510(k)

SPI ELEMENT DENTAL IMPLANT O 3.5 MM

K-Number: K030689 · 2003-03-26

ApplicantThommen Medical AG
Decision Date2003-03-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPI ELEMENT DENTAL IMPLANT O 3.5 MM is the device name listed in this FDA 510(k) record. The listed applicant is Thommen Medical AG. It received FDA 510(k) clearance on 2003-03-26 under 510(k) number K030689. 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 SPI ELEMENT DENTAL IMPLANT O 3.5 MM?

SPI ELEMENT DENTAL IMPLANT O 3.5 MM is a medical device that received FDA 510(k) clearance on 2003-03-26. The listed applicant is Thommen Medical AG. The 510(k) number is K030689.

When did SPI ELEMENT DENTAL IMPLANT O 3.5 MM receive FDA 510(k) clearance?

SPI ELEMENT DENTAL IMPLANT O 3.5 MM received FDA 510(k) clearance on 2003-03-26, under 510(k) number K030689.

Who is the listed applicant for SPI ELEMENT DENTAL IMPLANT O 3.5 MM?

The FDA 510(k) record lists Thommen Medical AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPI ELEMENT DENTAL IMPLANT O 3.5 MM?

The FDA product code for SPI ELEMENT DENTAL IMPLANT O 3.5 MM is DZE.

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Other records listing Thommen Medical AG 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.

K171795Thommen Implant SystemK160244VARIOuniteK151984Thommen Milling Abutment for CAD/CAMK121334VARIOECOK111984SPI VARIO ANGLED ABUTMENTK102804SPI TITANIUM BASE FOR CAD/CAM

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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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