BIORESORB MACRO PORE

K050260 · Oraltronics Dental Implant Technology GmbH · LYC · Jul 15, 2005 · Dental

Device Facts

• Record ID: K050260
• Device Name: BIORESORB MACRO PORE
• Applicant: Oraltronics Dental Implant Technology GmbH
• Product Code: LYC · Dental
• Decision Date: Jul 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BioResorb® Macro Pore is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.

Device Story

BioResorb® Macro Pore is a synthetic, resorbable bone void filler composed of beta-tricalcium phosphate (β-TCP). It is intended for use by clinicians in dental and orthopedic procedures, including sinus lifts, ridge augmentation, and osseous defect repair. The material acts as a scaffold to support bone regeneration. It is supplied as a ceramic powder and is applied directly to the surgical site by the practitioner. The device provides a biocompatible, resorbable matrix that facilitates natural bone healing and remodeling. It is intended for prescription use only.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via bench testing and historical marketing data (marketed in Germany since 1988 with no reported adverse events). Bench testing confirms heavy metal content complies with ASTM 1088.

Technological Characteristics

Synthetic, resorbable β-TCP ceramic powder. Composition complies with ASTM 1088 (Standard specification for beta-TCP for implant surgery).

Indications for Use

Indicated for use as a bone void filler in guided tissue regeneration, sinus lifts, ridge maintenance, alveolar socket preservation, ridge augmentation, and treatment of osseous defects in patients requiring bone grafting.

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

• Curasan Cersorb® Ortho (K014156)

Submission Summary (Full Text)

{0}------------------------------------------------

K050260

# Section 2: 510(K) Summary of Safety and Effectiveness BioResorb® Macro Pore

JUL 1 5 2005

#### A. Submitters Information

| Name: | Oraltronics Dental Implant Technology GmbH. |
|---------------------|---------------------------------------------|
| Address: | Herrlichkeit 4<br>Bremen, DE 28199 |
| Telephone: | 49-421-4-39390 |
| Fax: | 49-421-4-43936 |
| Contact Person: | Dr. Greggory Cox |
| Date of Submission: | January 28, 2005 |

### B. Device Name

BioResorb® Macro Pore

# C. Predicate Device

Curasan Cersorb® Ortho, K014156, Curasan AG, Lindstrasse 4, Kleinostheim, Germany

# D. Device Description

BioResorb® Macro Pore ß tricalcium phosphate is a synthetic, resorbable bone void filling material.

#### E. Intended Use

BioResorb® Macro Pore is to be used as a bone void filler device used in guided tissue regeneration, sinus lifts. ridge maintenance, alveolar socket preservation or ridge augmentation and the treatment of osseous defects.

#### F. Technological Characteristics

The proposed BioResorb® Macro Pore and the predicate device Cerasorb® are of identical composition and are intended for the same use. The technological characteristics of the materials used are exact to the predicate device.

{1}------------------------------------------------

# G. Performance Data

BioResorb® is a ceramics powder of phase-three ß-TCP. It is manufactured from pure laboratory chemicals. The contents of heavy metal according to ASTM 1088 (Standard specification for beta-TCP for implant surgery) are far below the permissible levels. BioResorb® has been used and marketed in Germany since 1988 with no adverse events. The safety and effectiveness of this material ß-TCP in this application has been established.

The proposed BioResorb® Macro Pore device is substantially equivalent to the listed predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The logo is presented in black and white.

Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Oraltronics Dental Implant Technology GmbH C/O Mr. Chad Bartee Osteogenics Biomedical, Incorporated 3234 64th Street Lubbock, Texas 79413

Re: K050260

Trade/Device Name: BioResorb® Macro Pore Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 6, 2005 Received: July 7, 2005

Dear Mr. Bartee:

This letter corrects our substantially equivalent letter of July 15, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. Bartee

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA Sissuance on a substanted of a complies with other requirements mean that FDA has made a decemination administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by seggtreat of the Act of ally rederal statues and regirements, including, but not limited to: registration
You must comply with all the Act's requirements, including arguited You must comply with an the Fee brequirement) art 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Part 801); and i and listing (21 CFR Fall 807), lacemig (21 CFR are 600); }
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality Systems (20) regisions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section I his letter will anow you to continue manoming your dence of your device to 310(K) premaiket nonfleation: "The PDF 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), 11 you desire specifice of Compliance at [phone] please contact the Office of Comphanis.html#OC for OC organization structure). Also, please (http://www.ida.gov/currorganishranding by reference to premarket notification" (21 CFR)
note the regulation entitled, "Misbranding by reference to premarket ikilities under note the regulation childed, "Miberananing of information on your responsibilities under the Part 807.97). 1 ou may obtain other general international and Consumer Assistance at its Act from the DrAbion 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qur

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510 (K) Submission BioResorb® Macro Pore

510(k) Number (if known): 050260

Device Name:__BioResorb® Macro Pore

Indications for Use:

BioResorb® is to be used as a bone void filler device used in guided tissue DIOKESOFUL Is to be assure a commenance, alveolar socket preservation or ridge augmentation, and the treatment of osseous defects.

Prescription Use __ X_ (Per 21 CFR 801.109) OR

Over-the-Counter Usc (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz DDS for Dr. Susan Runner

eral Hospital. Infection

510(k) Number

Oraltronics Dental Implant Technology GmbH BioResorb® Macro Pore 510 (K)

8