BIOPLANT

K050984 · Kerr Dental Materials Center · LYC · Aug 11, 2005 · Dental

Device Facts

• Record ID: K050984
• Device Name: BIOPLANT
• Applicant: Kerr Dental Materials Center
• Product Code: LYC · Dental
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Bioplant is to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the following indications: 1) To maintain and restore the bony alveolar ridge after extraction of tooth-roots. i.e., Ridge preservation/Socket grafting, 2) To restore infra-bony defects caused by destructive periodontal discase, i.e., 2-3 wall defects/Class I, II and III furcations, 3) To augment bony defects, i.e., apicocctomics, cystic formation or turnor removal, 4) Ridge augmentation to restore the height and/or width of severcly atrophicd alveolar ridges, 5) Augmentations in the maxillary sinus, 6) Bone voids associated with implant replacement.

Device Story

Bioplant is a synthetic, non-resorbable, radio-opaque bone void filler used in oral and maxillofacial surgery. It consists of 750-micron poly methylmethacrylate (PMMA) beads coated with poly hydroxyethyl methacrylate (PHEMA) for hydrophilicity, barium sulfate for radio-opacity, and calcium hydroxide to promote bone growth. The porous structure supports bony tissue ingrowth. The device is supplied sterile via gamma radiation. It is intended for use by dental professionals to address defects resulting from tooth extraction, periodontal disease, surgery, or atrophy, and to support implant placement. By filling voids, it provides a scaffold for natural bone regeneration, aiding in the restoration of alveolar ridge height and width.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Synthetic polymer bone void filler. Materials: PMMA beads, PHEMA coating, barium sulfate, calcium hydroxide. Particle size: 750 microns. Porous structure. Radio-opaque. Sterilization: Gamma radiation.

Indications for Use

Indicated for patients requiring filling, augmentation, or reconstruction of periodontal or bony defects in the oral and maxillofacial region, including ridge preservation/socket grafting, infra-bony defects (2-3 wall, Class I-III furcations), apicoectomies, cystic/tumor removal, ridge augmentation for atrophy, maxillary sinus augmentation, and bone voids associated with implant placement.

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

• Ostim Bone Grafting Material
• Biomet Inc., HTR-MX

Submission Summary (Full Text)

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K050984

#### SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: April 2005

#### Device Name:

- Trade Name Bioplant �
- Common Name Synthetic Bone Grafting Material .
- Classification Name Unclassified �

### Dovices for Which Substantial Equivalence is Claimed:

- Heracus Kulzer, Ostim Bone Grafting Material .
- Biomet Inc., HTR- MX .

### Device Description:

Bioplant is a synthetic polymer bone void filling material which, due to its porosily characteristics, is capable of supporting ingrowth of bony tissue. This non-resorbable and radio-opaque material is used to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region. The material consists of poly methylmethacrylate (PMMA) beads coated with poly hydroxyethyl methacrylate (PHEMA) to increase hydrophlicity of the porous structure, a thin layer of barium sulfate for radio-opacity, and calcium hydroxide for hydrophilicity and to promote bone growth around the PMMA beads. The average particle size of the beads is 750 microns. The product is sterliked using gamma radiation.

### Intended Use of the Device:

The intended use of Bioplant is to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the following indications: 1) To maintain and restore the bony alveolar ridge after extraction of tooth-roots. i.e., Ridge preservation/Socket grafting, 2) To restore infra-bony defects caused by destructive periodontal discase, i.e., 2-3 wall defects/Class I, II and III furcations, 3) To augment bony defects, i.e., apicocctomics, cystic formation or turnor removal, 4) Ridge augmentation to

> 1717 West Intlins Avenua, Grange, CA 02867 800 537-7824 714 316-7400

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restore the height and/or width of severcly atrophicd alveolar ridges, 5) Augmentations in
ternations of the many idential was sisted with implant replacement. restore the height and/or within of severery and pith implant replacement.
The maxillary sinus, 6) Bone voids associated with implant replacement.

## Substantial Equivalence:

Bioplant is substantially equivalent to other legally marketed devices in the United States.
The product Bioplant is substantially equivalent is intended for the same ilse as the product
Bioplant functions in a manner similar to and is intended for the supplier to and is Bioplant functions in a monder simmal its mostions in a mancer similar to and is
Ostin Bone Grafting Material and Higherstocked by Magacons Kulzer and Biol Ostim Bone Grafting Mulerial and Bropham Iunches in a mainer Minister and Biomet Inc.,
composed of the same materials as HTR-MX marketed by Heracus Kulzer and Biomet Inc., respectively.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The logo is surrounded by text that reads "U.S. Department of Health and Human Services, USA" in a circular arrangement.

Public Health Service

AUG 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerr Dental Materials Center C/O Ms. Colleen Boswell Director, Corporate Compliance Division of Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K050984

Trade/Device Name: BIOPLANT Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: II Product Code: LYC Dated: July 28, 2005 Received: July 29, 2005

Dear Ms. Boswell:

We have reviewed your Section 510(k) premarket notification of intent to market the devices we nave reviewed your occasion 910(x) premium in the device is substantially equivalent (for the indications felerenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regars annual date of the Medical Device Amendments, or to connitered proc to May 20, 1978, the ensordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). alle Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the devices, only of the ments for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (500 abs regulations affecting major regulations affecting your device can
may be subject to such additional controls. Existing major and contro may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I sams concerning your device in the Federal Register.

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Page 2 - Ms. Boswell

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 that I DA has made a dotenments and regulations administered by other Federal agencies. You must of any I ederal statutes and regaraments, including, but not limited to: registration and listing (21 Comply with an the Fee of requirements,
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CrK Fart 607), ademig (21 OFR Part 820); and if applicable, the electronic form in the quality by sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation control provisions (Seeting your device as described in your Section 510(k) I mis iciter with anow you're oogin finding of substantial equivalence of your device to a legally prematics notification: "The Presults 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 If you desire specific at no notialize at [phone]. Also, please note the regulation entitled, Comaci the Office of Comment of Crification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Quitte J. Michie MD

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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K050984

# Indications for Use

510(k) Number (if known):

Device Name: Bioplant

Indications For Use:

Rioplant is a synthetically derived, spherical material which is intended to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region in the below indications.

- 1) To maintain and restore the bony alveolar ridge after extraction of tooth-roots, i.e., Ridge preservation/Socket grafting;
- 2) To restore infra-bony defects caused by destructive periodontal disease, i.e., 2-3 wall defects/Class I, II and III furcations;
- 3) To augment bony defects, i.e., apicocctomies, cystic formation or tumor removal;
- 4) Ridge augmentation to restore the height and/or width of severely atrophicd alveolar ridges;
- 5) Augmentations in the maxillary sinus;
- () Trone voids associated with implant placement.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLUASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Susan Rumsey

Division of Anesthesiglos Infection Control. Den

510(k) Number: K050984

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