OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)

K053374 · Ossacur AG · LYC · Feb 21, 2006 · Dental

Device Facts

• Record ID: K053374
• Device Name: OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)
• Applicant: Ossacur AG
• Product Code: LYC · Dental
• Decision Date: Feb 21, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - Filling of periodontal defects. - Filling of defects after root resection, apicoectomy, and cystectomy. - Filling of extraction sockets to enhance preservation of the alveolar ridge. - Elevation of the maxillary sinus floor. - Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for GBR.

Device Story

OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque β-tricalcium phosphate (β-TCP) ceramic bone grafting material. Supplied as granulate in sterile glass vials; used by dental surgeons in clinical settings to fill or reconstruct bony defects in the oro-maxillofacial region. Osteoconductive properties support bone regeneration; material is resorbed over time. Used alone or in conjunction with GTR/GBR products to enhance alveolar ridge preservation or treat peri-implant defects. Provides a scaffold for new bone growth; benefits patient by restoring bone volume and structural integrity.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Material: pure-phase β-tricalcium phosphate (β-TCP) conforming to ASTM F1088-04. Form: granulate. Properties: radiopaque, osteoconductive, high interconnecting porosity. Sterilization: sterile (sealed glass vials in Tyvek pouches).

Indications for Use

Indicated for patients requiring filling, augmentation, or reconstruction of periodontal or bony defects in the oro-maxillofacial region, including alveolar ridge augmentation, extraction socket preservation, and maxillary sinus floor elevation.

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

• calc-i-oss® (K042583)
• Cerasorb® DENTAL (K051443)

Submission Summary (Full Text)

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K05337 Lt

Image /page/0/Picture/1 description: The image shows the word "OSSACUR" in a bold, sans-serif font. A thick, black arc is positioned above and below the word, creating a circular enclosure around it. The arcs are symmetrical and curve upwards, adding a sense of visual containment to the text.

FEH ! 1 2006

# 510(K) Summary

### A. Submitter Information

| Submitter's Name: | OSSACUR® AG |
|----------------------|-----------------------|
| Address: | Benzstrasse 2 |
| | D-71720 |
| | Oberstenfeld, Germany |
| Phone Number: | ([phone] |
| Fax Number: | ([phone] |
| Contact Person: | Arne Briest |
| Date of Preparation: | November 30, 2005 |

#### B. Device Name

| Trade Name: | OSSAPLAST™ DENTAL |
|----------------------|-------------------------------|
| Common/Usual Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material |
| | §872.3930 (Product Code: LPK) |

## C. Predicate Devices

| Trade Name: | calc-i-oss® (K042583) |
|-------------|----------------------------|
| Trade Name: | Cerasorb® DENTAL (K051443) |

## D. Device Description

OSSAPLAST DENTAL is a synthetic, implantable, resorbable, radiopaque βtricalcium phosphate (β-ΤCP) ceramic in granulate form. It consists of purephase β-ΤCP [Саз(РОд)½] and is csteoconductive, with high interconnecting porosity.

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OSSAPLAST DENTAL is supplied sterile in sealed glass vials, in various quantities. Each vial is packaged inside a Tyvek pouch to assure a double sterile configuration.

#### E. Intended Use

OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for GBR.

#### F. Technological Characteristics Summary

OSSAPLAST DENTAL does not incorporate any new technological characteristics as compared to the predicate devices. OSSAPLAST DENTAL and the predicate devices are made from the same material (pure-phase β-TCP) and conform to the standard specifications of ASTM F1088-04 for a medical grade β-TCP to be used in surgical implant applications. OSSAPLAST DENTAL is substantially equivalent to the predicate devices in regard to structure, porosity, form, packaging, sterility, and biocompatibility.

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Image /page/2/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 eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ossacur AG C/O Ms. Kristi Kistner Pacific Otter Works, Incorporated 975 Veronics Springs Road Santa Barbara, California 93105

Re: K053374

Trade/Device Name: OSSAPLAST DENTAL™ Bone Grafting Material Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 30, 2005 Received: December 5, 2005

Dear Ms. Kistner:

This letter corrects our substantially equivalent letter of February 21, 2006.

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.

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Page 2 - Ms. Kistner

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that I DTS issuained on that your device complies with other requirements mean mat ITDA nas made a deceminations administered by other Federal agencies. of the Act of ally 1 oderal bake and sequirements, including, but not limited to: registration Tour must comply with an the Free Stop (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 807), laceming (21 CFR Part 820), and if requirents as set form in the quality ison control provisions (sections 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 ins letter will anow you to continue manage of substantial equivalence of your device to 510(K) premailted 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), please contact the Office of Compliance at [phone] (http://www.fda.gov/cdrh/organiz.html#0C for OC organization structure). Also, please (fittp://www.laa.gow.caring by reference to premarket notification" (21 CFR note the regulation entired, "Thister general information on your responsibilities under the r at 607.97). Tourinay 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,

C. Arlen Price, Ph.D.

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

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# SECTION I-E.

# Statement of Indications for Use

510(k) Number (if known): ڀر ڇڏڪوڪو

Device Name: OSSAPLAST™ DENTAL Bone Grafting Material

Indications for Use:

OSSAPLAST DENTAL is intended for use in filling, augmenting, or reconstructing periodontal or bony defects of the oro-maxillofacial region. It is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.
- Filling of periodontal defects.
- Filling of defects after root resection, apicoectomy, and cystectomy.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of peri-implant defects in conjunction with products intended for GBR.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunner

rology, General Hospital,
and Dental Devices

K053374

Page 1 of 1OSSACUR® AG

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