CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO

K051443 · Curasan Ag, Frankfurt Facility · LYC · Jul 22, 2005 · Dental

Device Facts

• Record ID: K051443
• Device Name: CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO
• Applicant: Curasan Ag, Frankfurt Facility
• Product Code: LYC · Dental
• Decision Date: Jul 22, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for : - Augmentation or reconstructive treatment of the alveolar ridge - - Filling of infrabony 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). Cerasorb® Perio is recommended for: - Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of infrabony periodontal defects - Filling of single-or multi-wall bone pockets - Filling of bifurcations and trifurcations

Device Story

Synthetic bone void fillers (Cerasorb DENTAL, M DENTAL, Perio) composed of pure-phase Beta-Tricalcium Phosphate. Provided as granules or polygonal morsels. Applied by clinicians to bony defects in oral/maxillofacial/dental procedures. Material is osteoconductive; resorbs in contact with vital bone; gradually replaced by new host bone. Facilitates bone regeneration in periodontal and alveolar ridge applications. Single-use; sterile.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on material composition, biocompatibility, and performance characteristics compared to predicate bone void fillers.

Technological Characteristics

Material: Pure-phase Beta-Tricalcium Phosphate (compliant with ASTM F 1088-04). Structure: Interconnecting porosity (approx. 25-65 vol% depending on design). Form: Granules or polygonal morsels. Energy: None. Connectivity: None. Sterilization: Gamma irradiation.

Indications for Use

Indicated for dental/oral/maxillofacial bone void filling, including alveolar ridge augmentation, infrabony periodontal defects, extraction sockets, maxillary sinus floor elevation, and defects following root resection, apicoectomy, or cystectomy. Used in conjunction with GTR/GBR products for periodontal defects, bone pockets, and bifurcations/trifurcations.

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

• Cerasorb DENTAL (PMA800035)
• PerioGlas (K992416, K040278)
• BIO-OSS Collagen (K033815)
• BIO-OSS Anorganic Bovine Bone (K970321)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human figures, possibly symbolizing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2007

Curasan AG, Frankfurt Facility C/O Mr. Eric Weichert President Applications Specialist International, Incorporated 109 Shore Drive Garner, North Carolina 27529

Re: K051443

Trade/Device Name: Cerasorb® Dental, Cerasorb® M Dental, and Cerasorb® Perio Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: May 31, 2005 Received: June 2, 2005

Dear Mr. Weichert:

This letter corrects our substantially equivalent letter of August 3, 2005.

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 - Mr. Weichert

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 continue 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 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#OC for OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Chiu-Liang 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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## Cerasorb® M DENTAL

### Indications for Use

### KOSI443 510(k) Number (if known):

Cerasorb® M DENTAL Device Name:

Indications for Use:

Cerasorb® M DENTAL is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge.

- Filling of infrabony periodontal defects.
- Filling of miracony person resection, apicoectorny, and cystectorny.
- Filling of extraction sockets to enhance preservation of the alveolar ridge.
- Elevation of the maxillary sinus floor.
- Elevation of periodontal defects in conjunction with products intended for Filling of perfodonali action (GTR) and Guided Bone Regeneration (GBR).
- Guided Tissue Regenciation (Oric) and Cattler with products intended for Guided Bone Regeneration (GBR).

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert DDS for Dr. Susan Rumner

(Division Sian-Off Division of Anesthesiology, General Hospital, Infection Control. Dental De

510(k) Number:

Page 1 of 1_

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### Statements of Indications for Use 1.4

Cerasorb® DENTAL

## Indications for Use

KOS 1443 510(k) Number (if known):

Cerasorb® DENTAL Device Name:

Indications for Use:

Cerasorb® DENTAL is recommended for:

- Augmentation or reconstructive treatment of the alveolar ridge. -
- Filling of infrabony 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 a Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Gulded I Issue Regenciation (OTT) ... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -Guided Bone Regeneration (GBR).

Prescription Use _

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-Olif)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

Page 1 of 1

510(k) Number:_

13 - 6

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### Cerasorb® Perio

## Indications for Use

KOSIYYZ 510(k) Number (if known):

Cerasorb® Perio Device Name:

Indications for Use:

Cerasorb® Perio is recommended for:

- Filling and/or reconstruction of non-infected periodontal bone defects in conjunction with other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets.
- Filling of bifurcations and trifurcations

> Prescription Use __

. AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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JUL 2 2 2 2005

Image /page/5/Picture/1 description: The image shows the word "curasan" in a bold, sans-serif font. The letters are black and appear to be slightly distorted, giving them a rounded, almost cartoonish look. The word is presented in a single line, with each letter connected to the next.

K051443

# Abbreviated 510 (k) Summary:

Cerasorb® DENTAL Cerasorb® M DENTAL Cerasorb® Perio

### SUBMISSION INFORMATION 1.

| Name and Address of the Sponsor: | curasan AG<br>Lindigstrasse 4<br>63801 Kleinostheim<br>Germany |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dr. Wolf-Dietrich Huebner, MD<br>Medical Director<br>Tel.: +49 – 6027 – 4686-325<br>Fax: +49 – 6027 – 4686-433<br>E – Mail: [e-mail] |
| Registered U. S. Agent: | Dr. Eric Wiechert, Ph.D.<br>109 Shore Drive<br>Garner, NC 27529, USA<br>Phone: 919 – 772-8518, fax: 919 – 772-1300<br>E – Mail: [e-mail] |

### DEVICE IDENTIFICATION 2.

| Proprietary Name: | Cerasorb® DENTAL<br>Cerasorb® M DENTAL<br>Cerasorb® Perio |
|-----------------------------------|--------------------------------------------------------------|
| Common Name: | Bone Void Filler, Synthetic |
| Classification Name : | Bone Grafting Material, Synthetic |
| Classification: | Class II, Special Controls |
| Classification regulation Number: | 21CFR 872.3930 |
| Product Code: | LPK, Tricalcium Phosphate Granules for Dental<br>Bone Repair |

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#### PREDICATE DEVICES 3.

Cerasorb® DENTAL: PMA800035 PerioGlas®: K992416, K040278 FENOGILS . RO-OSS® BLOCKS, BIO-OSS® Collagen: K033815 BIO-OSS® Anorganic Bovine Bone: K970321

#### INTENDED USE 4.

Cerasorb® DENTAL and Cerasorb® M DENTAL are recommended for :

- Augmentation or reconstructive treatment of the alveolar ridge -
- Filling of infrabony 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 -
- Eievaton of the maxmaly since new
Filling of periodontal defects in conjunction with products intended for Guided -Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filside Regeneration (Cris) ats in conjunction with products intended for Guided -Bone Regeneration (GBR)

Cerasorb® Perio is recommended for:

- Filling and/or reconstruction of non-infected periodontal bone defects in Filling and/or "reconstration" other products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of infrabony periodontal defects
- Filling of single-or multi-wall bone pockets
- Filling of bifurcations and trifurcations

### DESCRIPTION OF THE DEVICE 5.

Cerasorb® DENTAL, Cerasorb® M DENTAL and Cerasorb® Perio are a sterile, Cerasorb DENTRE, Ceramic matrix in either granilar form (Cerasorb Syntifetic, polygonal shaped morsels (Cerasorb M DENTAL) or polygonal broken DENTAL), polygonal "shaped" morbols" (Soint of pure-phase Beta-Tricalcium Phosphate grandlate (Crasorb Ferro). This access. ply with the ASTM F 1088-04. The devices, when with a phase purry of - 9778 and compy make of large, smoothly intercomected pores applied to a bony defect, ereate a rto DENTAL approx. 35%, Cerasorb M DENTAL providing anterent porosity] and Cerasorb Perio approx. 25vol%).

approx. 05 v0170 [total porochy] and ored by a validated manufacturing process which The different designs are managed and reproducibility. Due to their synthetic nature guarantees battli to batch conformily and repredactions and are neither locally nor systemically toxic.

Iocally not systembally toxic.
In contact with vital bone the Cerasorb granules, morsels or granulate is resorbed and gradually replaced by new bone.

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Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are provided in double Cerason DENTAL, Cetasons in gamma irradiation) and are for single-use only.

### BASIS FOR SUBSTANTIAL EQUIVALENCE 6.

Cerasorb DENTAL, Cerasorb M DENTAL and Cerasorb Perio are substantially Celasolo DENTAL; Colusion -11- narketed and approved/cleared bone void fillers for defects in the oral/maxillofacial and dental region, such as Cerasorb DENTAL (the sponsors own device formally regulated as a PMA, PMA800035), BIO-OSS® Anorganic sponsors own device formally regulated as a Flass (K992416, K040278).

Bovine Dolle (1376521, 1635013) and ifferent (Beta-Tricalcium Phosphate vs. Bovine Although the source of the material), the intended use, recommended indications Bone vs. synthette blouerry glass material site, and performance data fr the three Cerasorb for use, and the predicate devices are essentially similar. Also, all materials are designs and biocompatible. In contact with vital bone any of the bone grafting materials is resorbed and gradually replaced by new bone.

materials is resorded and gradually replasse of nones the effectiveness and safety of the Cerasorb designs compared to the predicate devices.

### STATEMENT OF TECHNOLOGICAL COMPARISON 7.

All Cerasorb design modifications consist of pure phase Beta-Tricalcium Phosphate All Cerason design modified on the 1088-04. The material is of intercomnecting porosity, osteoconductive and resorbable.