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FDA 510(k)

CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)

K-Number: K873683 · 1987-11-16

ApplicantPentron Corp.
Decision Date1987-11-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Corp.. It received FDA 510(k) clearance on 1987-11-16 under 510(k) number K873683. 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 CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)?

CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) is a medical device that received FDA 510(k) clearance on 1987-11-16. The listed applicant is Pentron Corp.. The 510(k) number is K873683.

When did CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) receive FDA 510(k) clearance?

CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) received FDA 510(k) clearance on 1987-11-16, under 510(k) number K873683.

Who is the listed applicant for CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)?

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 CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL)?

The FDA product code for CODE #23 R SYSTEM (DENTIN ADHESIVE MATERIAL) 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 KITK874162OPTEC STAIN CHARACTERIZATION AND MODIFICATION KITK873878#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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