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FDA 510(k)

ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE

K-Number: K960596 · 1996-04-26

ApplicantDent Zar, Inc.
Decision Date1996-04-26
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE is the device name listed in this FDA 510(k) record. The listed applicant is Dent Zar, Inc.. It received FDA 510(k) clearance on 1996-04-26 under 510(k) number K960596. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE?

ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE is a medical device that received FDA 510(k) clearance on 1996-04-26. The listed applicant is Dent Zar, Inc.. The 510(k) number is K960596.

When did ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE receive FDA 510(k) clearance?

ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE received FDA 510(k) clearance on 1996-04-26, under 510(k) number K960596.

Who is the listed applicant for ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE?

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

What is the FDA product code for ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE?

The FDA product code for ORION-I CORE BUILD-UP MATERIAL CHEMICAL CURE is EBF.

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Other records listing Dent Zar, 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.

K962277SELF CURE BONDING AGENTK960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETSK960600LEXUR ENAMEL COATING-PORCELAIN REPAIR-BONDING VENEERSK960595FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETSK960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CUREK960598CONCORD MARYLAND BRIDGE CEMENT

View all 12 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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