A-Oss

K151542 · Hiossen, Inc. · NPM · Aug 3, 2016 · Dental

Device Facts

• Record ID: K151542
• Device Name: A-Oss
• Applicant: Hiossen, Inc.
• Product Code: NPM · Dental
• Decision Date: Aug 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas. - Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction - Filling in the missing part of a bone surrounding an implant - Maxillary sinus lift for implant - Alveolar bone augmentation/restoration

Device Story

A-Oss is a bone grafting material used in dental procedures. It serves as a scaffold for bone regeneration in defects caused by periodontal disease, cysts, or extractions, and is used for alveolar ridge augmentation and maxillary sinus lifts. The material is placed by a dentist or oral surgeon into the bone defect site to facilitate natural bone growth and integration. It provides structural support for dental implants and restores bone volume. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on regulatory classification and intended use comparison.

Technological Characteristics

Bone grafting material classified under 21 CFR 872.3930 (Product Code: NPM). Material properties and specific standards are not detailed in the provided documentation.

Indications for Use

Indicated for dental patients requiring bone defect filling or bone augmentation, including cases of periodontal disease, cystectomy, dental extraction, implant site preparation, maxillary sinus lift, and alveolar bone restoration.

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.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 3, 2016

Hiossen Inc. Mr. David Kim Manager 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K151542

Trade/Device Name: A-Oss® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: June 24, 2016 Received: June 24, 2016

Dear Mr. Kim:

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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Image /page/2/Picture/0 description: The image shows the logo and contact information for Hiossen Inc. The address is 85 Ben Fairless Dr. Fairless Hills, PA 19030. The phone number is 1-888-678-0001 and the fax number is 1-267-759-7004. The website is www.hiossen.com.

510(k) Number K_151542

Trade Name: A-Oss

## Indication for use :

A-Oss® is applicable in filling of the bone defect and bone augmentation in the following dental areas.

- Filling in the missing part of a bone due to periodontal disease, cystectomy, or dental extraction
- Filling in the missing part of a bone surrounding an implant
- Maxillary sinus lift for implant
- Alveolar bone augmentation/restoration

Prescription Use _ X (Per 21CFR801 Subpart D) OR Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)