STONEGLASS DENTAL LABORATORY PTY LTD

Address:Unit 26,,Sydney New South Wales,AU

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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

Dentures, Full (NSL) (5) Restoration, Resin, Crown And Bridge (NSN) (5)

Premarket Exempt

Yes

Clear

Stoneglass Industries - D101SGI1040 Catalog Number : SGI104

Device Description : Replacement crown and repair for ABC+E prosthesis

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI1050 Catalog Number : SGI105

Device Description : Temporary Prosthesis Assembled with Temporary Cylinders

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI1080 Catalog Number : SGI108

Device Description : Replacement crown and repair for ABC+Z prosthesis

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI160 Catalog Number : SGI16

Device Description : Fixed Prototype Prosthesis with Denture Teeth

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI180 Catalog Number : SGI18

Device Description : ABC+D Prosthesis (Denture Teeth)

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI190 Catalog Number : SGI19

Device Description : ABC+E Prosthesis (eMax)

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI200 Catalog Number : SGI20

Device Description : ABC+Z Prosthesis (Zirconia)

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI220 Catalog Number : SGI22

Device Description : ABC+DR Removable Prosthesis (Denture Teeth)

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI50 Catalog Number : SGI5

Device Description : Complete Denture with Metal Reinforcement

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSL

Prescription Use : Yes

Device Count : 1

Stoneglass Industries - D101SGI650 Catalog Number : SGI65

Device Description : Replacement Toothcard for ABC+D

Device Class :

Duns Number: 751548632

Premarket Exempt : Yes

Product Code : NSN

Prescription Use : Yes

Device Count : 1

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