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FDA 510(k)

COMFORT CONTROL SYRINGE SYSTEM

K-Number: K002387 · 2000-09-28

ApplicantDentsply Intl.
Decision Date2000-09-28
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMFORT CONTROL SYRINGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2000-09-28 under 510(k) number K002387. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT CONTROL SYRINGE SYSTEM?

COMFORT CONTROL SYRINGE SYSTEM is a medical device that received FDA 510(k) clearance on 2000-09-28. The listed applicant is Dentsply Intl.. The 510(k) number is K002387.

When did COMFORT CONTROL SYRINGE SYSTEM receive FDA 510(k) clearance?

COMFORT CONTROL SYRINGE SYSTEM received FDA 510(k) clearance on 2000-09-28, under 510(k) number K002387.

Who is the listed applicant for COMFORT CONTROL SYRINGE SYSTEM?

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

What is the FDA product code for COMFORT CONTROL SYRINGE SYSTEM?

The FDA product code for COMFORT CONTROL SYRINGE SYSTEM is EJI.

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Related Devices (Code: EJI)

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.

K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc.K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg. Co., LLCK113247ANESTHESIA INJECTION TOOL SETKi Works Co., Ltd.K082249MORPHEUSMeibach Tech LtdaK092943ASPIRATING SYRINGE, NON-ASPIRATING SYRINGEArnold Tuber IndustriesK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTMiltex, 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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