SELANE 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

Device, Jaw Repositioning (LQZ) (10)

Premarket Exempt

Clear

SML - D85463225AS1 Catalog Number :

Device Description : ADJUSTABLE DORSAL-ACRYLIC

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463226S1 Catalog Number :

Device Description : ADJUSTABLE DORSAL/PMT

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250AHS1 Catalog Number :

Device Description : HERBST ZYPPAH HYBRID

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250AS1 Catalog Number :

Device Description : UCLA ADJUSTABLE MODIFIED HERBST

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250PS1 Catalog Number :

Device Description : PMT BASED MODIFIED HERBST

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250S1 Catalog Number :

Device Description : UCLA (CLARK) MOD HERBST

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250SLS1 Catalog Number :

Device Description : UCLA ADJ MODIFIED HERBST SL

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463250TS1 Catalog Number :

Device Description : UCLA MOD.HERBST/TALON

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463251S1 Catalog Number :

Device Description : UCLA MOD. HERBST-ONE SEGMENT U OR L

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

SML - D85463252S1 Catalog Number :

Device Description : ADJUSTABLE HERBST HINGE

Device Class : 2

Duns Number: 066642729

Premarket Exempt : No

Product Code : LQZ

Prescription Use : No

Device Count : 1

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