CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.

Address:Unit 43 - 1909 Oxford Street East,LONDON Ontario,CA

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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

SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL (EID) (7) TIP, RUBBER, ORAL HYGIENE (JEW) (3) MATERIAL, IMPRESSION (ELW) (1)

Premarket Exempt

No Yes

Clear

Template® Ultra Quick Matrix Material 4pk - 07540172000574 Catalog Number : 028904

Device Description : Ultra Quick Matrix Material

Device Class : 1

Duns Number: 626406016

Premarket Exempt : No

Product Code : EID, ELW

Prescription Use : No

Device Count : 1

Dual Port Impression Gun - 07540172000581 Catalog Number : 031120

Device Description : Two-component dental material applicator, manual

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

Small (yellow) Intraoral Tips - 07540172000598 Catalog Number : 032120

Device Description : Dental restorative material canula, single-use

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

2.5 Mixing Tips with Integrated Needle - 07540172000604 Catalog Number : 032252

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : JEW

Prescription Use : No

Device Count : 1

3.2 Mixing Tips with Integrated Needle - 07540172000611 Catalog Number : 032253

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : JEW

Prescription Use : No

Device Count : 1

4.2 Mixing Tips with Integrated Needle - 07540172000628 Catalog Number : 032254

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : JEW

Prescription Use : No

Device Count : 1

Yellow Intraoral Tips - 07540172000635 Catalog Number : 032520

Device Description : Dental restorative material canula, single-use

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

4.2 Dual-Port Mixing Tips (100-pack) - 07540172000642 Catalog Number : 033121

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

5.4 Dual-Port Mixing Tips (100-pack) - 07540172000659 Catalog Number : 033123

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

7.5 Mixing Tips - 07540172000666 Catalog Number : 033124

Device Description : Dental material mixing nozzle, non-sterile

Device Class : 1

Duns Number: 626406016

Premarket Exempt : Yes

Product Code : EID

Prescription Use : No

Device Count : 1

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