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FDA 510(k)

PERTAC II/PERTAC II APLITIP

K-Number: K962440 · 1996-09-11

ApplicantEspe GmbH & Co. Kg.
Decision Date1996-09-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERTAC II/PERTAC II APLITIP is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH & Co. Kg.. It received FDA 510(k) clearance on 1996-09-11 under 510(k) number K962440. 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 PERTAC II/PERTAC II APLITIP?

PERTAC II/PERTAC II APLITIP is a medical device that received FDA 510(k) clearance on 1996-09-11. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K962440.

When did PERTAC II/PERTAC II APLITIP receive FDA 510(k) clearance?

PERTAC II/PERTAC II APLITIP received FDA 510(k) clearance on 1996-09-11, under 510(k) number K962440.

Who is the listed applicant for PERTAC II/PERTAC II APLITIP?

The FDA 510(k) record lists Espe GmbH & Co. Kg. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERTAC II/PERTAC II APLITIP?

The FDA product code for PERTAC II/PERTAC II APLITIP is EBF.

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Other records listing Espe GmbH & Co. Kg. 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.

K974231POSITION PENTA, POSITION PENTA QUICKK973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUERK973262KETAC-FIL APLICAP PLUSK972892CAVIT-LCK963735COJET SYSTEMK963737HYCEM APLICAP

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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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