Dental Health Products Inc

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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

Bur, Dental (EJL) (4) Material, Impression (ELW) (3) Material, Tooth Shade, Resin (EBF) (3)

Premarket Exempt

No Yes

Clear

Health-Tec Bite Registration Material - D7731502021 Catalog Number : 150-202

Device Description : Health-Tec Bite Registration Material, Fast Set, Cool Mint

Device Class :

Duns Number: 623191194

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

Health-Tec Bite Registration Material - D773150202B1 Catalog Number : 150-202B

Device Description : Health-Tec Bite Registration Material, Fast Set, Cool Mint, Bulk Pack

Device Class :

Duns Number: 623191194

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 25

Health-Tec Bite Registration Material - D7731502031 Catalog Number : 150-203

Device Description : Health-Tec Bite Registration Material, Super Fast Set, Cool Mint

Device Class :

Duns Number: 623191194

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 2

DHP Carbide Burs - D773180HTEF61 Catalog Number : 180-HTEF6

Device Description : DHP Carbide Burs EF6 5/pkg

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 5

DHP Carbide Burs - D773180HTFE41 Catalog Number : 180-HTEF4

Device Description : DHP Carbide Burs EF4 5/pkg

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 5

DHP Carbide Burs - D773180HTFE91 Catalog Number : 180-HTEF9

Device Description : DHP Carbide Burs EF9 5/pkg

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 5

DHP Carbide Burs - D773180HTFG11 Catalog Number : 180-HTFG1

Device Description : DHP Carbide Burs #1 FG 10/pkg

Device Class : 1

Duns Number: 623191194

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : No

Device Count : 10

Health-Tec Flowable Composite - D773210HT10A11 Catalog Number : 210-HT10A1

Device Description : Health-Tec Flowable Composite Refill Shade A1

Device Class :

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

DHP Nanohybrid Flowable Composite - D773210HT10A121 Catalog Number : 210-HT10A12

Device Description : DHP Nanohybrid Flowable Composite Refill A1 2-2gm syringes

Device Class : 2

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Health-Tec Flowable Composite - D773210HT10A21 Catalog Number : 210-HT10A2

Device Description : Health-Tec Flowable Composite Refill Shade A2

Device Class :

Duns Number: 623191194

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 2

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