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FDA 510(k)

NEODENT GRAFT SCREW

K-Number: K103084 · 2011-02-14

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S
Decision Date2011-02-14
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEODENT GRAFT SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S. It received FDA 510(k) clearance on 2011-02-14 under 510(k) number K103084. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEODENT GRAFT SCREW?

NEODENT GRAFT SCREW is a medical device that received FDA 510(k) clearance on 2011-02-14. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S. The 510(k) number is K103084.

When did NEODENT GRAFT SCREW receive FDA 510(k) clearance?

NEODENT GRAFT SCREW received FDA 510(k) clearance on 2011-02-14, under 510(k) number K103084.

Who is the listed applicant for NEODENT GRAFT SCREW?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEODENT GRAFT SCREW?

The FDA product code for NEODENT GRAFT SCREW is DZL.

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Other records listing Jjgc Industria E Comercio DE Materiais Dentarios S 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.

K153624Neodent Implant SystemK123022NEODENT IMPLANT SYSTEMK102769NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGEK101945NEODENT IMPLANT SYSTEMK101207NEODENT IMPLANT SYSTEM

Related Devices (Code: DZL)

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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbH

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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