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

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

Premarket Exempt

Clear

ASTRON 1180 - D8101180EC11 Catalog Number : 1180EC1

Device Description : DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON 1180 - D8101180LFT11 Catalog Number : 1180LFT1

Device Description : DENTURE MATERIAL - 10 UNIT KIT - 10 each 25 gram units

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON 1180 - D8101180MFT11 Catalog Number : 1180MFT1

Device Description : DENTURE MATERIAL - 10 UNIT KIT - 10 EACH 25 GRAM UNITS

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON LC - D810LCH818 Catalog Number : LCH81

Device Description : DENTURE MATERIAL -8 PACK KIT - PACKAGE 8 EACH 6 GRAMS POWDER / 4 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON LC - D810LCHE11 Catalog Number : LCHE1

Device Description : DENTURE MATERIAL - ECONO KIT - PACKAGE 180 GRAMS POWDER/120 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON LC - D810LCS818 Catalog Number : LCS81

Device Description : DENTURE MATERIAL - 8 UNIT KIT - PACKAGE 8 EACH 6.3 GRAMS POWDER / 4 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

ASTRON LC - D810LCSE11 Catalog Number : LCSE1

Device Description : DENTURE MATERIAL - ECONO KIT - PACKAGE 180 GRAMS POWDER/120 GRAMS LIQUID

Device Class : 2

Duns Number: 056624901

Premarket Exempt : No

Product Code : EBI

Prescription Use : No

Device Count : 1

The Original Clearsplint Disc - D810PCSD1698111 Catalog Number : PCSD16

Device Description : Package of 1 disc 98mmX16mm with shoulder

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

The Original Clearsplint Disc - D810PCSD2095Z111 Catalog Number : PCSD95

Device Description : Package of 1 disc 95mmX20mm Zirkonzahn/Clover Leaf Edge

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

The Original Clearsplint Disc - D810PCSD2098NS111 Catalog Number : PCSD98N

Device Description : Package of 1 disc 98mmX20mm with no shoulder

Device Class : U

Duns Number: 056624901

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

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