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FDA 510(k)

REPROBONE DENTAL GRAFTING MATERIAL

K-Number: K103820 · 2011-11-03

ApplicantCeramisys, Ltd.
Decision Date2011-11-03
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPROBONE DENTAL GRAFTING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Ceramisys, Ltd.. It received FDA 510(k) clearance on 2011-11-03 under 510(k) number K103820. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPROBONE DENTAL GRAFTING MATERIAL?

REPROBONE DENTAL GRAFTING MATERIAL is a medical device that received FDA 510(k) clearance on 2011-11-03. The listed applicant is Ceramisys, Ltd.. The 510(k) number is K103820.

When did REPROBONE DENTAL GRAFTING MATERIAL receive FDA 510(k) clearance?

REPROBONE DENTAL GRAFTING MATERIAL received FDA 510(k) clearance on 2011-11-03, under 510(k) number K103820.

Who is the listed applicant for REPROBONE DENTAL GRAFTING MATERIAL?

The FDA 510(k) record lists Ceramisys, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROBONE DENTAL GRAFTING MATERIAL?

The FDA product code for REPROBONE DENTAL GRAFTING MATERIAL is LYC.

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Other records listing Ceramisys, Ltd. 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.

K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEX

Related Devices (Code: LYC)

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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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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