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510(k) K002387

COMFORT CONTROL SYRINGE SYSTEM by Dentsply Intl. — Product Code EJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2000
Date Received
August 4, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Cartridge
Device Class
Class II
Regulation Number
872.6770
Review Panel
DE
Submission Type

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  • K081694 — DENJECTOR (September 12, 2008)
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  • K043322 — MIRAMATIC SAFE SYRINGE SYSTEM (July 21, 2005)