IMPLANTECH ASSOCIATES, INC.

Address:6025 NICOLLE ST., SUITE B,Ventura,CA,93003,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

Elastomer, Silicone, For Scar Management (MDA) (6) Prosthesis, Chin, Internal (FWP) (4)

Premarket Exempt

No Yes

Clear

Widening Mandibular Angle™ - M724WMA7LNS1 Catalog Number : WMA-7L-NS

Device Description : Mandibular Implant

Device Class : 2

Duns Number: 784664955

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Widening Mandibular Angle™ - M724WMA7R1 Catalog Number : WMA-7R

Device Description : Mandibular Implant

Device Class : 2

Duns Number: 784664955

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Widening Mandibular Angle™ - M724WMA7RNS1 Catalog Number : WMA-7R-NS

Device Description : Mandibular Implant

Device Class : 2

Duns Number: 784664955

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Widening Mandibular Angle™ Sizers - M724WMASIZNS1 Catalog Number : WMA-SIZ-NS

Device Description : Widening Mandibular Angle™ Sizers

Device Class : 2

Duns Number: 784664955

Premarket Exempt : No

Product Code : FWP

Prescription Use : Yes

Device Count : 1

Gelzone Wrap - M724WRAP10481 Catalog Number : WRAP-1048

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP1048NL1 Catalog Number : WRAP-1048-NL

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP1121 Catalog Number : WRAP-112

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP2121 Catalog Number : WRAP-212

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP2161 Catalog Number : WRAP-216

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

Gelzone Wrap - M724WRAP4121 Catalog Number : WRAP-412

Device Description : Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression

Device Class : 1

Duns Number: 784664955

Premarket Exempt : No

Product Code : MDA

Prescription Use : No

Device Count : 1

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