Product code DZN— Dental

FDA has cleared 16 devices under product code DZN between 1978 and 2012, filed by 14 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 20121 clearance
• 20071 clearance
• 19901 clearance
• 19861 clearance
• 19842 clearances
• 19822 clearances
• 19803 clearances
• 19793 clearances
• 19782 clearances

• Howmedica Corp.2 clearances
• Den-Mat Corp.2 clearances
• World Wide Outdoor Marketing1 clearance
• Sybron Corp.1 clearance
• Parker Laboratories, Inc.1 clearance
• Moyco Industries, Inc.1 clearance
• Kerrhawe SA1 clearance
• Ivoclar North America, Inc.1 clearance
• Healthco, Inc.1 clearance
• Fly Cast Technologies, Inc.1 clearance

• K111465 — COMPOTHIXOKerrhawe SA·2012-07-25
• K071858 — DENTAL MATRIX BANDFly Cast Technologies, Inc.·2007-08-31
• K901919 — CONTACT MOLAR BANDS AND CONTOUR STRIPSIvoclar North America, Inc.·1990-06-22
• K861581 — CENTRIX PCR MOLAR MATRIX FORMS (BANDS)Centrix, Inc.·1986-05-12
• K844324 — TIGER BANDWorld Wide Outdoor Marketing·1984-12-03
• K840984 — INTERDENTAL WEDGESHealthco, Inc.·1984-04-13
• K822094 — DENTAL MATRIX BANDDentsply Intl.·1982-08-16
• K821444 — COLORED WEDGE USED TO SEPARATE TEETHMoyco Industries, Inc.·1982-06-14
• K801142 — PALODENT MATRICES & BITINE RINGSAlvin Meyer, D.D.S.·1980-08-07
• K801530 — COREFORM MOLDSSybron Corp.·1980-07-28
• K790555 — HEMO-WEDGEParker Laboratories, Inc.·1980-01-17
• K790599 — RUWA MATRIX STRIPSHowmedica Corp.·1979-05-21
• K790600 — HOWMEDICA STRIP CROWNHowmedica Corp.·1979-05-21
• K790633 — ACCOR MATRIXAccor, Inc.·1979-05-17
• K772314 — WEDGES, RETAINING, MATRIXDen-Mat Corp.·1978-01-03
• K772316 — MATRIX STRIP, DEAD-SOFTDen-Mat Corp.·1978-01-03