POLIDENT d.o.o.

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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

Denture, plastic, teeth (ELM) (10)

Premarket Exempt

No Yes

Clear

CROSS LINKED 2 - EPOLCL01C2 Catalog Number : CL.01C2

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01C3 Catalog Number : CL.01C3

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01C4 Catalog Number : CL.01C4

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01D2 Catalog Number : CL.01D2

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01D3 Catalog Number : CL.01D3

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01D4 Catalog Number : CL.01D4

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL01L3 Catalog Number : CL.01L3

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL02A1 Catalog Number : CL.02A1

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL02A2 Catalog Number : CL.02A2

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

CROSS LINKED 2 - EPOLCL02A3 Catalog Number : CL.02A3

Device Description : Resin Artificial Teeth

Device Class : 2

Duns Number: 644778409

Premarket Exempt : Yes

Product Code : ELM

Prescription Use : No

Device Count : 1

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