CANDID CARE CO.

Address:34 South Third Street,Columbus,OH,43215,US

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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) (9) Retractor, All Types (EIG) (9) Tray, Impression, Preformed (EHY) (9) Aligner, Sequential (NXC) (1)

Premarket Exempt

Clear

Candid Impression Kit - 00850004223109 Catalog Number :

Device Description : Candid finished impression kit (Mesh Impression Tray)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Impression Kit - 00850004223116 Catalog Number :

Device Description : Candid finished impression kit (Mesh Impression Tray + Kett Putty)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Impression Kit - 00850004223123 Catalog Number :

Device Description : Candid finished impression kit (Old Tray + Kett Putty + Digital)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Redo Impression Kit - 00850004223130 Catalog Number :

Device Description : Redo Impression Kit (Small Trays)Kett PuttyDigital

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Redo Impression Kit - 00850004223147 Catalog Number :

Device Description : Redo Impression Kit (Medium Trays)Kett PuttyDigital

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Redo Impression Kit - 00850004223154 Catalog Number :

Device Description : Redo Impression Kit (Large Trays)Kett PuttyDigital

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : ELW, EHY, EIG

Prescription Use : Yes

Device Count : 1

Candid Impression Kit - 00850004223161 Catalog Number :

Device Description : Candid finished impression kit (Old Tray + Kulz Putty + Digital)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : EIG, EHY, ELW

Prescription Use : Yes

Device Count : 1

Candid Impression Kit - 00850004223178 Catalog Number :

Device Description : Candid finished impression kit (Mesh Impression Tray Low + Reg Impression Tray Up)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : EIG, EHY, ELW

Prescription Use : Yes

Device Count : 1

Candid Impression Kit - 00850004223185 Catalog Number :

Device Description : Candid finished impression kit (Old Tray + Kett Putty + Digital)

Device Class : 1

Duns Number: 108729170

Premarket Exempt : No

Product Code : EIG, EHY, ELW

Prescription Use : Yes

Device Count : 1

Candid Aligner - 00850004223222 Catalog Number :

Device Description : Candid Aligner System FA-0003

Device Class : 2

Duns Number: 108729170

Premarket Exempt : No

Product Code : NXC

Prescription Use : Yes

Device Count : 1

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