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FDA 510(k)

NORIAN PERIODONTAL/DENTAL CEMENT (PDC)

K-Number: K983104 · 1999-02-12

ApplicantNorian Corp.
Decision Date1999-02-12
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORIAN PERIODONTAL/DENTAL CEMENT (PDC) is the device name listed in this FDA 510(k) record. The listed applicant is Norian Corp.. It received FDA 510(k) clearance on 1999-02-12 under 510(k) number K983104. 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 NORIAN PERIODONTAL/DENTAL CEMENT (PDC)?

NORIAN PERIODONTAL/DENTAL CEMENT (PDC) is a medical device that received FDA 510(k) clearance on 1999-02-12. The listed applicant is Norian Corp.. The 510(k) number is K983104.

When did NORIAN PERIODONTAL/DENTAL CEMENT (PDC) receive FDA 510(k) clearance?

NORIAN PERIODONTAL/DENTAL CEMENT (PDC) received FDA 510(k) clearance on 1999-02-12, under 510(k) number K983104.

Who is the listed applicant for NORIAN PERIODONTAL/DENTAL CEMENT (PDC)?

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

What is the FDA product code for NORIAN PERIODONTAL/DENTAL CEMENT (PDC)?

The FDA product code for NORIAN PERIODONTAL/DENTAL CEMENT (PDC) is LYC.

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 Norian Corp. 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.

K973789NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CCK882098DENTORIDGE(TM) HYDROXYYLAPATITE

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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