Straumann BoneCeramic

K201051 · Institut Straumann AG · LYC · Sep 24, 2020 · Dental

Device Facts

• Record ID: K201051
• Device Name: Straumann BoneCeramic
• Applicant: Institut Straumann AG
• Product Code: LYC · Dental
• Decision Date: Sep 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® BoneCeramic is intended to be used for filling and/or augmenting intraoral/maxillofacial osseous defects.

Device Story

Straumann® BoneCeramic is a synthetic, osteoconductive bone graft substitute composed of biphasic calcium phosphate (60% hydroxyapatite, 40% beta-tricalcium phosphate). It features 90% porosity with interconnected pores (100-500 microns). Supplied as sterile granules in two size ranges (400-700 µm and 500-1000 µm), it is used by dental clinicians to fill or augment osseous defects in the oral/maxillofacial region. The material acts as a scaffold, gradually resorbing and being replaced by the patient's vital bone during the natural remodeling process. It is intended for surgical implantation to support bone regeneration in periodontal, alveolar, and sinus grafting procedures.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993. Packaging validated per ISO 11607 and ASTM F1980. Sterilization validated per ISO 11137. Pyrogenicity confirmed via LAL Endotoxin Analysis (limit 20 EU/device). Clinical performance supported by a review of 18 clinical publications and a 13.5-year post-market complaint rate of <0.05%.

Technological Characteristics

Synthetic biphasic calcium phosphate (60% hydroxyapatite, 40% beta-tricalcium phosphate). 90% porosity; interconnected pores 100-500 µm. Granule sizes: 400-700 µm and 500-1000 µm. Sterilization: Gamma irradiation. Packaging: Polystyrene jar, polypropylene cap, PETG blister, Tyvek lid.

Indications for Use

Indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, including intrabony periodontal osseous and furcation defects, augmentation of alveolar ridge bony defects, filling of tooth extraction sites, and sinus elevation grafting.

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

• Straumann Granules (K040646)

Submission Summary (Full Text)

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September 24, 2020

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K201051

Trade/Device Name: Straumann® BoneCeramic Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC Dated: August 23, 2020 Received: August 25, 2020

Dear Jennifer Jackson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K201051

### Device Name:

Straumann® BoneCeramic

Indications for Use (Describe)

Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

- Intrabony periodontal osseous and furcation defects
- Augmentation of bony defects of the alveolar ridge ●
- Filling tooth extraction sites ●
- Sinus elevation grafting .

Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Straumann® BoneCeramic

510(k) Summary

#### 510(k) Summary 5

#### 5.1 Submitter's Contact Information

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 900505-<br>On the behalf of:<br>Institut Straumann AG<br>Peter Merian-Weg 12<br>CH-4002 Basel, Switzerland |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: [phone]<br>Fax Number: [phone] |
| Prepared By: | Christelle Gerspach-Gasser<br>Senior Lead RA Biomaterials<br>Institut Straumann AG<br>Phone number: [phone] |
| Date Prepared: | September 23, 2020 |

#### Name of the Device 5.2

| Trade Names: | Straumann® BoneCeramic | |
|------------------------|-----------------------------------|--|
| Common Name: | Bone Grafting Material | |
| Classification Name: | Bone Grafting Material, Synthetic | |
| Regulation Number: | §872.3930 | |
| Device Classification: | II | |
| Product Code(s): | LYC | |
| Classification Panel: | Dental | |

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### Straumann® BoneCeramic

510(k) Summary

#### Predicate Device(s) 5.3

Primary Predicate:

- K040646 Straumann Granules .
#### 5.4 -Device Description

Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.

BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.

#### Intended Use 5.5

Straumann® BoneCeramic is intended to be used for filling and/or augmenting intraoral/maxillofacial osseous defects.

#### 5.6 Indications for Use

Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:

- . Intrabony periodontal osseous and furcation defects
- . Augmentation of bony defects of the alveolar ridge
- Filling tooth extraction sites .
- . Sinus elevation grafting

#### Technological Characteristics 5.7 -

The chemical composition, structure and indications for use of the subject device are identical to those of the predicate device. The only difference between the two relies in the different primary packaging utilized for the subject device. A comparison of the technological characteristics between the subject device and the primary predicate is provided in Table 1.

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### Straumann® BoneCeramic

### 510(k) Summary

| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | K201051 | K040646 |
| Indications for<br>use | Straumann® BoneCeramic is indicated for<br>filling and/or augmenting the following<br>intraoral/maxillofacial osseous defects:<br>Intrabony periodontal osseous and<br>furcation defects Augmentation of bony defects of the<br>alveolar ridge Filling tooth extraction sites Sinus elevation grafting | Straumann Granules are indicated for filling<br>and/or augmenting intraoral /maxillofacial<br>osseous defects, such as:<br>Intrabony periodontal osseous defects Furcation defects Augmentation of bony defects of the<br>alveolar ridge Filling of tooth extraction sites and<br>sinus elevation grafting. |
| Material<br>(Chemical<br>composition) | Hydroxyapatite (60%) and beta-tricalcium<br>phosphate (40%) | Hydroxyapatite (60%) and beta-tricalcium<br>phosphate (40%) |
| Structure /<br>Porosity | Matrix consisting of interconnected pores<br>(90% porosity), the size of the pores lies<br>within a range of approx. 100 – 500 microns<br>in diameter. | Matrix consisting of interconnected pores<br>(90% porosity), the size of the pores lies<br>within a range of approx. 100 – 500 microns<br>in diameter. |
| Particle sizes | 400 - 700 µm and 500 – 1000 µm | 400 - 700 µm and 500 – 1000 µm |
| Packaging | Sterile barrier system and protective<br>packaging:<br>1) Primary packaging: polystyrene jar closed<br>with a polypropylene cap<br>2) Secondary packaging: PETG blister<br>sealed with a Tyvek lid (sterile barrier)<br>3) Tertiary packaging: cardboard box | Sterile barrier system and protective<br>packaging:<br>1) Primary packaging: PET blister with PE<br>sealing layer<br>2) Secondary packaging: PET blister sealed<br>with a Tyvek lid (sterile barrier)<br>3) Tertiary packaging: cardboard box |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Biological<br>characteristics | Biocompatible | Biocompatible |

#### Performance Testing 5.8

Chemical characterization and biological testing were conducted according to the ISO standard for the biological evaluation of medical devices, ISO 10993, and to the FDA guidance document for this standard (FDA 2016, Use of International Standard ISO-10993). The new packaging material has been assessed in accordance to the above-mentioned standard and the biocompatibility of the device was confirmed. Furthermore, the packaging process and shelf life of the device have been validated per ISO 11607 and ASTM F1980.

The sterilization process for the subject device as indicated in the labeling has been validated according to ISO 11137 "Sterilization of health care products – Radiation", part 1 and 2. The

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### Straumann® BoneCeramic

### 510(k) Summary

devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis on every batch with a testing limit of 20 EU/device, based on a blood contacting and implanted device.

Device marketing and complaint history and review of the relevant clinical literature was provided. Over a period of 13.5 years, the overall complaint rate based on individual units sold globally for the subject devices was <0.05%. The review of the relevant clinical literature included 18 clinical publications across the relevant indications for use: intrabony osseous and furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting. The device marketing and complaint history and review of the relevant clinical literature provided demonstrates successful product use.

#### 5.9 Conclusion

The documentation submitted in this premarket notification demonstrates that the subject devices are substantially equivalent to the predicate devices.