FRIOS ALGIPORE

K023799 · Friadent GmbH · LYC · Feb 5, 2003 · Dental

Device Facts

• Record ID: K023799
• Device Name: FRIOS ALGIPORE
• Applicant: Friadent GmbH
• Product Code: LYC · Dental
• Decision Date: Feb 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

FRIOS® ALGIPORE® is indicated for: - Treatment of intrabony defects . - Augmentation of bony defects of alveolar ridge . - Filling of extraction sites ● - Sinus elevation grafting .

Device Story

FRIOS® ALGIPORE® is an inorganic, biocompatible bone filling and augmentation material derived from calcium-encrusted sea algae. Processed to create an apatite material analogous to bone apatite; provided sterile in pre-filled vials with granular size 300-2000 microns. Used by dental professionals in clinical settings for bone grafting procedures. Acts as a scaffold for bone regeneration in dental defects. Clinical benefit derived from its osteoconductive properties, facilitating repair of alveolar and intrabony defects.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative chemical and mineralogical analysis against predicate devices.

Technological Characteristics

Inorganic, biocompatible calcium phosphate material derived from sea algae. Granular form (300-2000 microns). Sterile. Composition verified via ICP-AES and X-Ray Diffraction to meet ASTM standards for Hydroxylapatite for surgical implants.

Indications for Use

Indicated for dental patients requiring bone filling and augmentation, specifically for treatment of intrabony defects, alveolar ridge augmentation, filling of extraction sites, and sinus elevation 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

• Interpore® 200 Granular Coralline Hydroxylapatite (K950165)
• OsteoGraf® / N-700 (K981214)

Submission Summary (Full Text)

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### SUMMARY OF SAFETY AND EFFECTIVENESS FEB 0 5 2003 SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

#### SUBMITTER INFORMATION 16.1

| a. Company Name: | FRIADENT GmbH. |
|-----------------------------------------|----------------------------------------------------|
| b. Company Address: | Steinzeugstrasse 50<br>Mannheim D-68229<br>Germany |
| c. Company Phone:<br>Company Facsimile: | (011) 49 621 43 02 1121<br>(011) 49 621 43 02 2121 |
| d. Contact Person: | Heike Dietzler<br>Regulatory Affairs Manager |
| e. Date Summary Prepared: | November 11, 2002 |

## 16.2. DEVICE IDENTIFICATION

| a. Trade/Proprietary Name: | FRIOS® ALGIPORE® |
|----------------------------|--------------------------------------------------------|
| b. Classification Name: | Bone Filling and Augmentation Material<br>Unclassified |
| c. Product Code: | LYC |

#### IDENTIFICATION OF PREDICATE DEVICES 16.3

| Company | Device | 510(k) No. | Date Cleared |
|----------------------------|------------------------------------------------------|------------|--------------|
| Interpore<br>International | Interpore® 200 Granular<br>Coralline Hydroxylapatite | K950165 | 03/28/1995 |
| CeraMed Dental | OsteoGraf® / N-700 | K981214 | 06/26/1998 |

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#### 16.4 DEVICE DESCRIPTION

FRIOS® ALGIPORE® is a bone filling and augmentation material indicated for use in dental applications. FRIOS® ALGIPORE® is an inorganic, biocompatible calcium phosphate material derived from calcium-encrusted sea algae. The algae are processed in order to develop an apatite material that is analogous to bone apatite. FRIOS® ALGIPORE® is provided sterile in pre-filled vials and has a granular size range from 300 - 2000 microns.

#### 16.5 SUBSTANTIAL EQUIVALENCE

FRIOS® ALGIPORE® is substantially equivalent to Interpore International Interpore® 200 Granular Coralline Hydroxylapatite in terms of material composition, chemical analysis, functionality and intended use. FRIOS® ALGIPORE® is also substantially equivalent to CeraMed Dental OsteoGraf® / N-700 in terms of material, functionality, and intended use.

#### INTENDED USE 16.6

FRIOS® ALGIPORE® is indicated for:

- Treatment of intrabony defects .
- Augmentation of bony defects of alveolar ridge .
- Filling of extraction sites ●
- Sinus elevation grafting .

#### TECHNOLOGICAL CHARACTERISTICS 16.7

FRIOS® ALGIPORE® is equivalent to Interpore 200 in terms of chemical composition. Comparison testing of the two materials was performed to determine the chemical and mineralogical composition using Inductively Coupled Argon Plasma Atomic Emission Spectroscopy (ICP-AES) and X-Ray Diffraction. Results of the testing showed that the materials are equivalent in composition and meet the ASTM standard specifications for the composition of Hydroxylapatite for surgical implants.

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#### 16.8 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Performance evaluations of the FRIOS® ALGIPORE® when tested in comparison to Interpore® 200 show that the materials are equivalent. Comparisons of the FRIOS® ALGIPORE® to the predicate devices show that the device is substantially equivalent.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

FRIADENT GmbH C/O Ms. Carol Patterson President Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest. California 92630

Re: K023799

Trade/Device Name: FRIOS® ALGIPORE® Regulation Number: None Regulation Name: Bone Filling and Augmentation Material Regulatory Class: Unclassified Product Code: LYC Dated: November 11, 2002 Received: November 14, 2002

Dear Ms. Patterson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 application (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 such 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.

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Page 2 - Ms. Patterson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kunrer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# INDICATION FOR USE

510(k) Number:

FRIOS® ALGIPORE® Device Name:

FRIOS® ALGIPORE® is indicated for: Indications for Use:

- Treatment of intrabony defects .
- Augmentation of bony defects of alveolar ridge ●
- Filling of extraction sites .
- Sinus elevation grafting ●

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

(Per 21 CFR 801.109)

*Ken Muhy for MSRC*

(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

| 510(k) Number: | K023799 |
|----------------|---------|
|----------------|---------|

CONFIDENTIAL