RHONDIUM LIMITED

Address:4 Sheffield Street,Katikati Bay of Plenty,NZ

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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

Material, Tooth Shade, Resin (EBF) (10)

Premarket Exempt

Clear

OVC™ One Visit Crown - 09421031790103 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A3 and size XS (extr Package contains an OVC for tooth number 12 or 13, in shade A3 and size XS (extra small), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790110 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A2 and size L (large Package contains an OVC for tooth number 14 or 15, in shade A2 and size L (large), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790127 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A3 and size L (large Package contains an OVC for tooth number 14 or 15, in shade A3 and size L (large), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790134 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A2 and size M (mediu Package contains an OVC for tooth number 14 or 15, in shade A2 and size M (medium), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790141 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A3 and size M (mediu Package contains an OVC for tooth number 14 or 15, in shade A3 and size M (medium), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790158 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A2 and size S (small Package contains an OVC for tooth number 14 or 15, in shade A2 and size S (small), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790165 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A3 and size S (small Package contains an OVC for tooth number 14 or 15, in shade A3 and size S (small), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790172 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A2 and size XL (extr Package contains an OVC for tooth number 14 or 15, in shade A2 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790189 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A3 and size XL (extr Package contains an OVC for tooth number 14 or 15, in shade A3 and size XL (extra large), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790196 Catalog Number :

Device Description : Package contains an OVC for tooth number 14 or 15, in shade A2 and size XS (extr Package contains an OVC for tooth number 14 or 15, in shade A2 and size XS (extra small), 4 x OVC wedges, a selector key and an OVC Replica

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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