LANG DENTAL MANUFACTURING CO., INC.

Address:175 MESSNER DR.,WHEELING,IL,60090,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) (10)

Premarket Exempt

No Yes

Clear

ORTHO-JET CRYSTAL POWDER - D6500230C0 Catalog Number : 0230C

Device Description : FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ORTHO-JET CRYSTAL - D6500234C0 Catalog Number : 0234C

Device Description : FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ORTHO-JET CRYSTAL POWDER - D6500250C0 Catalog Number : 0250C

Device Description : FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ORTHO-JET CRYSTAL - D6500256C0 Catalog Number : 0256C

Device Description : FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER AND LIQUID

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ORTHO-JET CRYSTAL POWDER - D6500280C0 Catalog Number : 0280C

Device Description : FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN POWDER

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

AVADENT / LANG DUPLICATION KIT - D6500323A0 Catalog Number : 0323A

Device Description : DENTURE DUPLICATION SYSTEM

Device Class : 2

Duns Number: 005185798

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

DENTURE DUPLICATOR KIT - D6500395K0 Catalog Number : 0395K

Device Description : DENTURE DUPLICATION SYSTEM

Device Class : 2

Duns Number: 005185798

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

IMPLANT DUPLICATOR KIT - D6500399K0 Catalog Number : 0399K

Device Description : SURGICAL GUIDE SYSTEM FOR IMPLANTS

Device Class : 2

Duns Number: 005185798

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

PREMIUM LIQUID - D6500704R0 Catalog Number : 0704R

Device Description : HEAT PROCESSED DENTURE ACRYLIC RESIN LIQUID

Device Class : 2

Duns Number: 005185798

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

PREMIUM LIQUID - D6500706R0 Catalog Number : 0706R

Device Description : HEAT PROCESSED DENTURE ACRYLIC RESIN LIQUID

Device Class : 2

Duns Number: 005185798

Premarket Exempt : Yes

Product Code : EBI

Prescription Use : Yes

Device Count : 1

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