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FDA 510(k)

SALVIN DENTAL SPECIALTIES FIXATION SCREW

K-Number: K100182 · 2010-05-10

ApplicantSalvin Dental Specialties, Inc.
Decision Date2010-05-10
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SALVIN DENTAL SPECIALTIES FIXATION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Salvin Dental Specialties, Inc.. It received FDA 510(k) clearance on 2010-05-10 under 510(k) number K100182. 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 SALVIN DENTAL SPECIALTIES FIXATION SCREW?

SALVIN DENTAL SPECIALTIES FIXATION SCREW is a medical device that received FDA 510(k) clearance on 2010-05-10. The listed applicant is Salvin Dental Specialties, Inc.. The 510(k) number is K100182.

When did SALVIN DENTAL SPECIALTIES FIXATION SCREW receive FDA 510(k) clearance?

SALVIN DENTAL SPECIALTIES FIXATION SCREW received FDA 510(k) clearance on 2010-05-10, under 510(k) number K100182.

Who is the listed applicant for SALVIN DENTAL SPECIALTIES FIXATION SCREW?

The FDA 510(k) record lists Salvin Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SALVIN DENTAL SPECIALTIES FIXATION SCREW?

The FDA product code for SALVIN DENTAL SPECIALTIES FIXATION SCREW is DZL.

Related Clinical Trials

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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Other records listing Salvin Dental Specialties, 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.

K073342SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW

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

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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