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Date Cleared

1996-08-20

(29 days)

Product Code

Regulation Number

Intended Use

Delivery of restorative and impression material.

Device Description

The PermaRidge syringe is a device used for the delivery of restorative and impression material. It is composed of a plastic barrel, polypropylene plunger, and rubber plunger tip.

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K Number

K962786

Device Name

OSTEOGRAF STAINLESS STEEL SYRING

Manufacturer

Date Cleared

1996-08-01

(15 days)

Product Code

Regulation Number

Intended Use

Delivery of restorative and impression material.

Device Description

The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.

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K Number

K960348

Device Name

OSTEOGRAF/N-300 HYDROXYLAPATITE

Manufacturer

Date Cleared

1996-04-22

(88 days)

Product Code

Regulation Number

Intended Use

The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

Device Description

OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

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K Number

K960353

Device Name

OSTEOGRAF/LD-300 HYDROXYLAPATITE

Manufacturer

Date Cleared

1996-04-18

(84 days)

Product Code

Regulation Number

Intended Use

for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

Device Description

OsteoGraf/LD-300 is a high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns.

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K Number

K960368

Device Name

OSTEOGRAFT/N-700 HYDROXYLAPTITE

Manufacturer

Date Cleared

1996-04-18

(84 days)

Product Code

Regulation Number

Intended Use

Device Description

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K Number

K960361

Device Name

PERMAMESH-D HYDROXYLAPATITE MATRIX

Manufacturer

Date Cleared

1996-04-15

(81 days)

Product Code

Regulation Number

Intended Use

Bone filling and/or augmentation of the alveolar ridge.

Device Description

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

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K Number

K960354

Device Name

PERMAMESH-D HYDROXYLAPATITE MATRIX

Manufacturer

Date Cleared

1996-03-20

(55 days)

Product Code

LZK

Regulation Number

878.3550

Intended Use

Facial (malar) restoration and augmentation,

Device Description

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

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K Number

K960362

Device Name

PERMAMESH HYDROXYLAPATITE MATRIX

Manufacturer

Date Cleared

1996-03-20

(55 days)

Product Code

LZK

Regulation Number

878.3550

Intended Use

Facial restoration and augmentation.

Device Description

PermaMesh is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

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K Number

K960349

Device Name

PERMARIDGE HYDROXYLAPATITE MATRIX

Manufacturer

Date Cleared

1996-03-13

(48 days)

Product Code

FWP

Regulation Number

878.3550

Intended Use

Facial restoration and augmentation.

Device Description

PermaRidge is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

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K Number

K954631

Device Name

OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE

Manufacturer