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 - 09421031790004 Catalog Number :

Device Description : The OVC Accessory Kit is a convenience kit for clinicians containing a procedura The OVC Accessory Kit is a convenience kit for clinicians containing a procedural aids.

Device Class : 2

Duns Number: 595078345

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

OVC™ One Visit Crown - 09421031790011 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A2 and size L (large Package contains an OVC for tooth number 12 or 13, 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 - 09421031790028 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A3 and size L (large Package contains an OVC for tooth number 12 or 13, 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 - 09421031790035 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A2 and size M (mediu Package contains an OVC for tooth number 12 or 13, 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 - 09421031790042 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A3 and size M (mediu Package contains an OVC for tooth number 12 or 13, 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 - 09421031790059 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A2 and size S (small Package contains an OVC for tooth number 12 or 13, 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 - 09421031790066 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A3 and size S (small Package contains an OVC for tooth number 12 or 13, 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 - 09421031790073 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A2 and size XL (extr Package contains an OVC for tooth number 12 or 13, 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 - 09421031790080 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A3 and size XL (extr Package contains an OVC for tooth number 12 or 13, 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 - 09421031790097 Catalog Number :

Device Description : Package contains an OVC for tooth number 12 or 13, in shade A2 and size XS (extr Package contains an OVC for tooth number 12 or 13, 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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