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FDA 510(k)

SIMPLANT ORTHO ; VISTADENT 3D

K-Number: K081402 · 2008-07-18

ApplicantMaterialise Dental NV
Decision Date2008-07-18
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIMPLANT ORTHO ; VISTADENT 3D is the device name listed in this FDA 510(k) record. The listed applicant is Materialise Dental NV. It received FDA 510(k) clearance on 2008-07-18 under 510(k) number K081402. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLANT ORTHO ; VISTADENT 3D?

SIMPLANT ORTHO ; VISTADENT 3D is a medical device that received FDA 510(k) clearance on 2008-07-18. The listed applicant is Materialise Dental NV. The 510(k) number is K081402.

When did SIMPLANT ORTHO ; VISTADENT 3D receive FDA 510(k) clearance?

SIMPLANT ORTHO ; VISTADENT 3D received FDA 510(k) clearance on 2008-07-18, under 510(k) number K081402.

Who is the listed applicant for SIMPLANT ORTHO ; VISTADENT 3D?

The FDA 510(k) record lists Materialise Dental NV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLANT ORTHO ; VISTADENT 3D?

The FDA product code for SIMPLANT ORTHO ; VISTADENT 3D is LLZ.

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Other records listing Materialise Dental NV 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.

K120733SIMPLANT GOK113739SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEMK112679SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEMK110300SIMPLANT 2011

Related Devices (Code: LLZ)

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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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