MDC DENTAL

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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, Impression (ELW) (6) Crown And Bridge, Temporary, Resin (EBG) (4)

Premarket Exempt

No Yes

Clear

MDC Dental - 07506338300193 Catalog Number :

Device Description : Bit register / fast set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300209 Catalog Number :

Device Description : Light body/normal set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300216 Catalog Number :

Device Description : Heavy body/normal set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300223 Catalog Number :

Device Description : Light body/normal set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300230 Catalog Number :

Device Description : Putty / fast set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300247 Catalog Number :

Device Description : Putty / normal set.Polyvinylsiloxane elastomer for making dental impressions.

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

Nic Tone, MDC Dental - 07506338300322 Catalog Number :

Device Description : Acrylic Temporary Resin for dental use, Tone BLEACH. Content: 1 Cartridge, with

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

Nic Tone, MDC Dental - 07506338300353 Catalog Number :

Device Description : Acrylic Temporary Resin for dental use, Tone A1. Content: 1 Cartridge, with 76 g

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

Nic Tone, MDC Dental - 07506338300360 Catalog Number :

Device Description : Acrylic Temporary Resin for dental use, Tone A2.Content: 1 Cartridge, with 76 g

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

MDC Dental - 07506338300377 Catalog Number :

Device Description : Tone A3. Box wit: 1 10:1 cartridge with 70g (50 ml) + 10 mixing tips + instructi

Device Class : 2

Duns Number: 811180298

Premarket Exempt : No

Product Code : EBG

Prescription Use : No

Device Count : 1

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