ASTRON DENTAL CORPORATION

Address:815 Oakwood Rd Ste G,Lake Zurich,IL,60047,US

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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

Mouthguard, Prescription (MQC) (7) Resin, Denture, Relining, Repairing, Rebasing (EBI) (3)

Premarket Exempt

Clear

The Original Clearsplint Disc - D810PCSD985111 Catalog Number : PCSD98

Device Description : Package of 1 disc 98mmX20mm with shoulder

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

CLEARSPLINT - D810PCSFEK11 Catalog Number : PCSFEK1

Device Description : DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

CLEARSPLINT - D810PCSFLK11 Catalog Number : PCSFLK1

Device Description : DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

CLEARSPLINT - D810PCSFSEK11 Catalog Number : PCSFSEK1

Device Description : DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

CLEARSPLINT - D810PCSREK11 Catalog Number : PCSREK1

Device Description : DENTURE MATERIAL - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

CLEARSPLINT - D810PCSRLK11 Catalog Number : PCSRLK1

Device Description : DENTURE MATERIAL - PACKAGE 160 GRAMS POWDER/120 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

CLEARSPLINT - D810PCSRSEK11 Catalog Number : PCSRSEK1

Device Description : DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/3 EACH 240 GRAMS LIQUID

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : No

Device Count : 1

LABTEC - D810PLT99EK11 Catalog Number : PLT99EK1

Device Description : DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/240 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

LABTEC - D810PLT99SEK11 Catalog Number : PLT99SEK1

Device Description : DENTURE MATERIAL - SUPER ECONO KIT - PACKAGE 960 GRAMS POWDER/ 3 EACH 240 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

LABTEC - D810PLTCLREK11 Catalog Number : PLTCLREK1

Device Description : DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER/ 240 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

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