CYTOPLAST REGENTEX TITANIUM 250

K972278 · Osteogenics Co. · LYC · Aug 6, 1997 · Dental

Device Facts

• Record ID: K972278
• Device Name: CYTOPLAST REGENTEX TITANIUM 250
• Applicant: Osteogenics Co.
• Product Code: LYC · Dental
• Decision Date: Aug 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Device Story

Cytoplast Regentex Titanium 250 is a non-absorbable barrier membrane used in periodontal surgery. Device consists of nanoporous high-density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. Nominal thickness is 250 microns. Supplied sterile in various shapes/sizes. Implanted by clinicians to act as a space-making barrier, preventing soft tissue ingrowth into periodontal bone defects to facilitate bone regeneration. Titanium framework provides structural support to maintain space. Biocompatibility established via historical use of PTFE and titanium. No clinical data or additional biocompatibility testing conducted.

Clinical Evidence

No clinical data provided. Biocompatibility is based on the long history of use of the constituent materials (PTFE and titanium).

Technological Characteristics

Nanoporous high-density polytetrafluoroethylene (n-PTFE) film with integrated titanium framework. Nominal thickness 250 microns. Sterile, non-absorbable barrier membrane. Mechanical space-making device.

Indications for Use

Indicated for use as a space-making barrier in the treatment of periodontal bone defects in patients requiring guided tissue regeneration.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Gore-Tex Regenerative Material (K960292)
• Cytoplast GBR Membrane (K964342)

Submission Summary (Full Text)

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K972278

UG - 6 1997

# 510 (k) SUMMARY

### ADMINISTRATIVE l.

Submitter: Osteogenics Co. 3234 64th Street Lubbock, TX 79413 [phone]

Contact Person: Barry K. Bartee, DDS

Date of Preparation: June 2, 1997

#### ll. DEVICE NAME

Proprietary Name: Cytoplast™ Regentex Titanium 250

Common Name: Non-Absorbable Barrier Membrane

Classification Name: Implant, Endosseous For Bone Filling And/Or Augmentation.

### PREDICATE DEVICES III.

Gore-Tex'" Reqenerative Material (K960292; W.L Gore & Associates, Inc.) Cytoplast " GBR Membrane (K964342; Osteogenics Co.)

## IV. DEVICE DESCRIPTION

The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.

The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.

#### V. INTENDED USE

A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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## VI. COMPARISON TO PREDICATE DEVICES

The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is identical in composition, function, and intended use to leqally marketed predicate devices such as Gore-Tex™ Regenerative Material. Except for the presence of a reinforcing titanium framework, the Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is also identical in composition, function, and intended use to the legally marketed predicate Cytoplast " GBR membrane.

Accordingly, Osteogenics Co. concluded that the Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is safe and effective for its intended use and performs at least as well as the legally marketed predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osteogenics Company C/O Richard Hamer Associates, Incorporated 6401 Meadows West Drive Fort Worth, Texas 76132

AUG - 6 1997

Re: K972278 Trade Name: Cytoplast Regentex Titanium 250 Requlatory Class: Unclassified Product Code: LYC Dated: June 17, 1997 Received: June 18, 1997

Dear Mr. Hamer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labelinq, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Farts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq

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Page 2 - Mr. Hamer

Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director

Division of Dental, Infection Control and General Hospital Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosed

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ol Paqe 1 1

510(k) Number (if known):

K922278

Cytoplast ''' Regentex Titaņium 250 Device Name: Non-Absorbable Barrier Membrane ...

Indications for Use:

A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDITIER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Num

Prescription Use
(Per 21 CFR 801.109)

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Over the Counter Use No

(Optional Format 1-2 96)