Bioplate, Inc.

Bioplate, Inc.

Address:570 S. Melrose St.,Placentia,CA,92870,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

Plate, Bone (JEY) (9) Drill, Dental, Intraoral (DZA) (1)

Premarket Exempt

No Yes

Clear

Bioplate® - M3818134840 Catalog Number : 81-3484

Device Description : Drill Bit - Ø1.5 mm x 10 mm

Device Class : 1

Duns Number: 838734093

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848110400 Catalog Number : 81-1040

Device Description : BioMesh® 3MC - 150 x 150 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848110410 Catalog Number : 81-1041

Device Description : BioMesh® 3MC - 90 x 120 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848110420 Catalog Number : 81-1042

Device Description : BioMesh® 3MC - 50 x 50 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848110430 Catalog Number : 81-1043

Device Description : BioMesh® 3MC - 100 x 150 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848110440 Catalog Number : 81-1044

Device Description : BioMesh® 3MC - 180 x 180 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M3848120001 Catalog Number : 81-2000

Device Description : Straight Plate - Ø1.5 mm - 2 hole - 11 mm [5 PK]

Device Class :

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 5

Bioplate® - M384812000US1 Catalog Number : 81-2000[US]

Device Description : Straight Plate - Ø1.5 mm - 2 hole - 11 mm [5 PK]

Device Class :

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 5

Bioplate® - M3848120010 Catalog Number : 81-2001

Device Description : Straight Plate - Ø1.5 mm - 4 hole - 19 mm

Device Class : 2

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

Bioplate® - M384812001CP1 Catalog Number : 81-2001-CP

Device Description : Straight Plate - Ø1.5 mm - 4 hole - 19 mm

Device Class :

Duns Number: 838734093

Premarket Exempt : No

Product Code : JEY

Prescription Use : Yes

Device Count : 1

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