Gestenco International AB

Gestenco International AB

Address:FRIDKULLAGATAN 14,GOTEBORG Vastra Gotaland,SE

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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

Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (6) Accessories, Retractor, Dental (EIF) (2) Bracket, Plastic, Orthodontic (DYW) (2)

Premarket Exempt

No Yes

Clear

SmartBond - 07333117000018 Catalog Number : SM-000

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

SmartBond - 07333117000025 Catalog Number : SM-010

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

SmartBond - 07333117000032 Catalog Number : SM-002

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

SmartBond - 07333117000049 Catalog Number : SM-001

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

SmartBond LC - 07333117000056 Catalog Number : SM-100-LC

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

SmartBond LC - 07333117000063 Catalog Number : SM-300-LC

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Bite-Bumper - 07333117000070 Catalog Number : BB-00-01

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Freddy - 07333117000087 Catalog Number : FCB-00-01

Device Class : 2

Duns Number: 354936098

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Cheek retractor - 07333117000148 Catalog Number : CR-00-01

Device Class : 1

Duns Number: 354936098

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

Lip Retractor - 07333117000162 Catalog Number : LR-00-01

Device Class : 1

Duns Number: 354936098

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

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