NORIAN PERIODONTAL/DENTAL CEMENT (PDC)

K983104 · Norian Corp. · LYC · Feb 12, 1999 · Dental

Device Facts

• Record ID: K983104
• Device Name: NORIAN PERIODONTAL/DENTAL CEMENT (PDC)
• Applicant: Norian Corp.
• Product Code: LYC · Dental
• Decision Date: Feb 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.

Device Story

Norian PDC is an injectable, moldable, biocompatible bone cement; consists of two sterile components: Calcium Phosphate Powder and Sodium Phosphate Solution. Components mixed in pneumatic mixer to form viscous paste; applied to operative site. Material cures in situ into carbonated apatite, chemically similar to bone mineral; gradually resorbed over time. Used by clinicians in dental/periodontal procedures to fill or augment bone defects. Provides structural support during healing process.

Clinical Evidence

Bench testing only. Biocompatibility testing confirmed material is acceptable for bone implant use; passed all tests for toxicity, mutagenicity, and irritation.

Technological Characteristics

Calcium phosphate-based bone cement; supplied as powder and liquid components. Cures to carbonated apatite. Applied via pneumatic mixer. Biocompatible, resorbable material. No software or electronic components.

Indications for Use

Indicated for patients requiring treatment of periodontal bone wall defects, extraction socket defects, and repair of cysts or other defects in the alveolar ridge or wall.

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

• BSM™ Bone Substitute Material Kit (K962548)
• Norian® Craniofacial Repair System™ (K973789)

Submission Summary (Full Text)

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2/12/99

Norian Corporation Skeletal Repair Systems

10260 Bubb Road Cupertino, CA 95014-4166 Phone [phone]

Fax [phone]

Ka 83104

510(k) Summary

### General Information

| Classification Name: | Bone Cement |
|-----------------------------|----------------------------------------------------------------------------------------------|
| Common Name: | Endosseous Implant for Bone Filling and/or Augmentation |
| Device Trade Name: | Norian® PDCTM |
| Submitter's Name & Address: | Norian Corporation<br>10260 Bubb Road<br>Cupertino, CA 95014-4166<br>[phone] |
| Contact Person: | Kim Tompkins, Vice President, Regulatory Affairs, Quality Assurance, and<br>Clinical Affairs |
| Summary Preparation Date: | September 1998 |

#### Device Description

Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.

#### Predicate Device

Norian PDC is substantially equivalent to legally marketed devices in the U.S. which are classified as endosseous implant for bone filling and/or augmentation, such as ~- BSM™ Bone Substitue Material Kit (K962548) and Norian® Craniofacial Repair System™ (K973789). Any minor differences between Norian PDC and the predicate devices do not raise new questions of safety or effectiveness.

#### Intended Use

Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.

#### Device Testing

Testing was designed and performed to characterize Norian PDC Cement. Biocompatibility testing showed that Norian PDC Cement is acceptable for its intended use as a bone implant material. Norian Cement passed all tests, and showed no toxic, mutagenic or irritating effect.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Ms. Kim Tompkins Vice President, Regulatory Affairs, Quality Assurance and Clinical Affairs Norian Corporation 10260 Bubb Road 95014-4166 Cupertino, California

Re: K983104

Norian® Periodontal/Dental Cement (PDC)™ Trade Name: Requlatory Class: III Product Code: LYC Dated: December 1, 1998 December 3, 1998 Received:

Dear Ms. Tompkins

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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Tompkins

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 fire reed in your 510(k) premarket notification. The FDA debtribut in four and equivalence of your device to a legally marketed predicate device results in a classification for your markets predicatore permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on compraise as (od advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Che regulation Chercled, "Hibbidian" (2) "Other general premation 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 at fes corr rrec namble (6): //www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known): K983104

Norian® Periodontal/Dental Cement™ (PDCTM) Device Name:

## Indications for Use:

Norian PDC Cement is intended to be used in the treatment of periodontal bone wall 1 the alves extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _V (Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Susa Rumes

(Division Sign-C Division of Dental, Infection Control, and General Hospital 510(k) Number