KEYSTONE DENTAL, INC.

Address:154 Middlesex Turnpike,BURLINGTON,MA,01803,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

BONE GRAFTING MATERIAL, HUMAN SOURCE (NUN) (5) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (5)

Premarket Exempt

Clear

DynaBlast - D7681022010500 Catalog Number : 10.220.1050

Device Description : Biomaterials

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

Accell Connexus - D7681031010500 Catalog Number : 10.310.1050

Device Description : Biomaterials

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

Accell Connexus - D7681031010600 Catalog Number : 10.310.1060

Device Description : Biomaterials

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

Accell Connexus - D7681031010700 Catalog Number : 10.310.1070

Device Description : Biomaterials

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

Accell Connexus - D7681031010800 Catalog Number : 10.310.1080

Device Description : Biomaterials

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : NUN

Prescription Use : Yes

Device Count : 1

Restore Implant System - D76811001K0 Catalog Number : 11001K

Device Description : Implant

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Restore Implant System - D76811002K0 Catalog Number : 11002K

Device Description : Implant

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Restore Implant System - D76811004K0 Catalog Number : 11004K

Device Description : Implant

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Restore Implant System - D76811006K0 Catalog Number : 11006K

Device Description : Implant

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Restore Implant System - D76811007K0 Catalog Number : 11007K

Device Description : Implant

Device Class : 2

Duns Number: 787471015

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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