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FDA 510(k)

VITAPEX PRE-LOADED DENTAL SYRINGE

K-Number: K973667 · 1997-11-06

ApplicantNeodental Chemical Products Co., Ltd.
Decision Date1997-11-06
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITAPEX PRE-LOADED DENTAL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Neodental Chemical Products Co., Ltd.. It received FDA 510(k) clearance on 1997-11-06 under 510(k) number K973667. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAPEX PRE-LOADED DENTAL SYRINGE?

VITAPEX PRE-LOADED DENTAL SYRINGE is a medical device that received FDA 510(k) clearance on 1997-11-06. The listed applicant is Neodental Chemical Products Co., Ltd.. The 510(k) number is K973667.

When did VITAPEX PRE-LOADED DENTAL SYRINGE receive FDA 510(k) clearance?

VITAPEX PRE-LOADED DENTAL SYRINGE received FDA 510(k) clearance on 1997-11-06, under 510(k) number K973667.

Who is the listed applicant for VITAPEX PRE-LOADED DENTAL SYRINGE?

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

What is the FDA product code for VITAPEX PRE-LOADED DENTAL SYRINGE?

The FDA product code for VITAPEX PRE-LOADED DENTAL SYRINGE is KIF.

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Other records listing Neodental Chemical Products Co., 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.

K111666EVADYNE TEMPORARY CROWN AND BRIDGE RESINK111668CAVIOS CAVITY LINERK971642DENTALIS KEZ ENDODONITC SEALERK955703NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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