ACE SURGICAL SUPPLY CO., INC.

Address:1034 Pearl St,BROCKTON,MA,02301,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

IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (10)

Premarket Exempt

No Yes

Clear

Infinity External Hex System - 00614950000326 Catalog Number : 01402112

Device Description : PREPABLE ABUTMENT HX 3.5HD 4CH 4.5CW W/SCREW 19502101

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000333 Catalog Number : 01402211

Device Description : PREPABLE ABUTMENT HX 4HD 5.5CW W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000340 Catalog Number : 01402411

Device Description : PREPABLE ABUTMENT HX 4HD 7CW W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000357 Catalog Number : 01402511

Device Description : PREPABLE ABUTMENT HX 5HD 5.5CW W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000364 Catalog Number : 01402611

Device Description : PREPABLE ABUTMENT HX 5HD 6.5CW W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000371 Catalog Number : 01402811

Device Description : PREPABLE ABUTMENT HX 5HD 7.5CW W/SCREW #19502001 (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000388 Catalog Number : 01402911

Device Description : PREPABLE ABUTMENT HX 6HD 6.5CW 2CH W/19502001

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Infinity External Hex System - 00614950000395 Catalog Number : 01402912

Device Description : PREPABLE ABUTMENT HX 6HD 4CH 6.5CW W/19502001

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE - 00614950000401 Catalog Number : 01403001

Device Description : PREPABLE ABUTMENT 15 DEG ANGLE DBLHX 4HD 4.5CW 2CH (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

ACE - 00614950000418 Catalog Number : 01403002

Device Description : PREPABLE ABUTMENT 15 DEG ANGLE DBLHX 4HD 4.5CW 4CH (TI6AL4VELI)

Device Class : 2

Duns Number: 042763706

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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