APPLIED DENTAL, 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

Suture, Nonabsorbable, Silk (GAP) (8) Explorer, Operative (EKB) (1) Mirror, Mouth (EAX) (1) Probe, Periodontic (EIX) (1) Suture, Nonabsorbable, Synthetic, Polyamide (GAR) (1)

Premarket Exempt

No Yes

Clear

UNIFY Silk Surgical Sutures - 00814639020298 Catalog Number :

Device Description : UNIFY Silk Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAR

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020601 Catalog Number :

Device Description : Silk, Med 3-0, 19mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020618 Catalog Number :

Device Description : Silk, Med 3-0/30", 19mm 3/8 Circle Rev Cut

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020625 Catalog Number :

Device Description : Silk, Med 4-0, 19mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020632 Catalog Number :

Device Description : Silk, Med 4-0/30", 19mm 3/8 Circle Rev Cut

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020649 Catalog Number :

Device Description : Silk, Med 5-0, 19mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020656 Catalog Number :

Device Description : Silk, Small 4-0, 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020663 Catalog Number :

Device Description : Silk, Small 5-0 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

UNIFY Silk Surgical Sutures - 00814639020670 Catalog Number :

Device Description : Silk, Small 6-0 13mm 3/8 Circle Rev Cut, 18"

Device Class :

Duns Number: 017524666

Premarket Exempt : No

Product Code : GAP

Prescription Use : No

Device Count : 1

I-pak - 00814639020694 Catalog Number : D002-009-P

Device Description : Sterile Dental I-pak (Intraoral Exam pack) with mirror, probe & explorer. Disposable.

Device Class :

Duns Number: 017524666

Premarket Exempt : Yes

Product Code : EAX, EIX, EKB

Prescription Use : Yes

Device Count : 1

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