Reliance Dental Manufacturing Co Inc

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Impression Tray, Resin (EBH) (8) Resin, Denture, Relining, Repairing, Rebasing (EBI) (2)

Premarket Exempt

No Yes

Clear

Dura Conditioner Bulk Package - White - D9471805 Catalog Number :

Device Description : Short term denture relining material/PACKAGE 4 LBS. POWDER / 4 - 16 OZ. LIQUID ( Short term denture relining material/PACKAGE 4 LBS. POWDER / 4 - 16 OZ. LIQUID (113 GR POWDER / 472 ML LIQUID EACH)

Device Class : 2

Duns Number: 005139159

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

Dura Conditioner Bulk Package - Pink - D9471805P1 Catalog Number :

Device Class : 2

Duns Number: 005139159

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

DURALAY - BLUE - D9472243B1 Catalog Number :

Device Description : INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - CLEAR - D9472243C1 Catalog Number :

Device Description : INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - Red - D9472244 Catalog Number :

Device Description : INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - BLUE - D9472244B1 Catalog Number :

Device Description : INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - CLEAR - D9472244C1 Catalog Number :

Device Description : INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - Red - D9472249A1 Catalog Number :

Device Description : INLAY PATTERN RESIN/8 OZ. POWDER / 8 OZ. LIQUID(224 GR POWDER / 240 ML LIQUID

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - BLUE - D9472249AB1 Catalog Number :

Device Description : INLAY PATTERN RESIN/8 OZ. POWDER / 8 OZ. LIQUID(224 GR POWDER / 240 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : No

Product Code : EBH

Prescription Use : No

Device Count : 1

DURALAY - CLEAR - D9472249AC1 Catalog Number :

Device Description : INLAY PATTERN RESIN/8 OZ. POWDER / 8 OZ. LIQUID(224 GR POWDER / 240 ML LIQUID)

Device Class : 1

Duns Number: 005139159

Premarket Exempt : Yes

Product Code : EBH

Prescription Use : No

Device Count : 1

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