SURE DENT CORPORATION

Address:#809, 52, SAGIMAKGOL-RO,SEONGNAM-SI Gyeonggi,KR

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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

Cord, Retraction (MVL) (6) Gutta-Percha (EKM) (3) Accessories, Retractor, Dental (EIF) (1)

Premarket Exempt

No Yes

Clear

Sure-endo - 08809264299098 Catalog Number :

Device Description : Sure-Cord, Knitted Non-medicated Gingival Retraction Cord, Size #3, 100 in (254cm)

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299814 Catalog Number :

Device Description : Gutta Percha Obturator, Size Hard, 100ea/box

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Sure-endo - 08809264299821 Catalog Number :

Device Description : Gutta Percha Obturator, Size Regular, 100ea/box

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Sure-endo - 08809264299838 Catalog Number :

Device Description : Gutta Percha Obturator, Size Soft, 100ea/box

Device Class : 1

Duns Number: 688273010

Premarket Exempt : Yes

Product Code : EKM

Prescription Use : Yes

Device Count : 100

Sure-endo - 08809264299883 Catalog Number :

Device Description : Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size # Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000.0, 100 in (254cm)

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299944 Catalog Number :

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299951 Catalog Number :

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299968 Catalog Number :

Device Description : Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size # Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #0, 100 in (254cm)

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299975 Catalog Number :

Device Description : Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size # Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #1, 100 in (254cm)

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

Sure-endo - 08809264299982 Catalog Number :

Device Description : Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size # Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #2, 100 in (254cm)

Device Class : U

Duns Number: 688273010

Premarket Exempt : No

Product Code : MVL

Prescription Use : Yes

Device Count : 1

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