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FDA 510(k)

OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT

K-Number: K874162 · 1988-01-12

ApplicantPentron Corp.
Decision Date1988-01-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Corp.. It received FDA 510(k) clearance on 1988-01-12 under 510(k) number K874162. 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 OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT?

OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT is a medical device that received FDA 510(k) clearance on 1988-01-12. The listed applicant is Pentron Corp.. The 510(k) number is K874162.

When did OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT receive FDA 510(k) clearance?

OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT received FDA 510(k) clearance on 1988-01-12, under 510(k) number K874162.

Who is the listed applicant for OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT?

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

What is the FDA product code for OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT?

The FDA product code for OPTEC STAIN CHARACTERIZATION AND MODIFICATION KIT is EBF.

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Other records listing Pentron 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.

K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIALK874189DUAL-CURE RADIOPAQUEK874275OPTEC SUPPLEMENTARY KITK873683CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)K873878#24L SYSTEMK864404PENTRON HIGH STRENGTH PORCELAIN

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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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