Geistlich Mucograft®, Geistlich Mucograft® Seal

K210280 · Geistlich Pharma AG · NPL · Mar 3, 2021 · Dental

Device Facts

• Record ID: K210280
• Device Name: Geistlich Mucograft®, Geistlich Mucograft® Seal
• Applicant: Geistlich Pharma AG
• Product Code: NPL · Dental
• Decision Date: Mar 3, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for: - covering of implants placed in immediate or delayed extraction sockets; - localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants; - alveolar ridge reconstruction for prosthetic treatment; and - recession defects for root coverage.

Device Story

Surgically implanted, fully resorbable porcine collagen matrix; used for oral tissue regeneration. Device features two-layer structure: smooth outer layer for suturing/soft tissue interface; porous inner layer for cell invasion/tissue integration. Placed by dental clinicians during oral surgical procedures. Facilitates wound healing and tissue integration. No cross-linking. Provided in various sizes/shapes (rectangles and circular seals).

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by leveraging mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance data from previously cleared predicate devices.

Technological Characteristics

Material: Porcine collagen. Structure: Dual-layer (smooth/porous). Sterilization: Gamma irradiation. Form factor: Rectangular matrices (15x20mm to 30x40mm) and circular seals (8mm, 12mm). Single-use. Non-cross-linked.

Indications for Use

Indicated for patients requiring oral tissue regeneration, including covering of implants in extraction sockets, localized gingival augmentation around teeth/implants, alveolar ridge reconstruction, and root coverage for recession defects.

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

• Geistlich Mucograft® and Mucograft® Seal (K192042)
• Geistlich Mucograft® and Mucograft® Seal (K140518)
• Geistlich Mucograft® and Mucograft® Seal (K102531)
• Geistlich Mucograft® and Mucograft® Seal (K073711)

Submission Summary (Full Text)

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March 03, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Geistlich Pharma AG % Roshana Ahmed Sr Regulatory Specialist TELOS Partners LLC 571 Christina Lake Drive Lakeland. Florida 33813

Re: K210280

Trade/Device Name: Geistlich Mucograft®, Geistlich Mucograft® Seal Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: January 30, 2021 Received: February 1, 2021

Dear Roshana Ahmed:

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 Actinclude 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 (QS) 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 (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 Andrew Steen Assistant 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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# Indications for Use

510(k) Number (if known) K210280

### Device Name

Geistlich Mucograft® and Geistlich Mucograft® Seal

Indications for Use (Describe) Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

- · covering of implants placed in immediate or delayed extraction sockets;
- · localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
- · alveolar ridge reconstruction for prosthetic treatment; and
- · recession defects for root coverage.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(k) Summary

#### I. Submitter

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: [phone]

Contact Person: Marco Steiner, Deputy Director Regulatory Affairs Date Prepared: March 3, 2021

#### II. Device

| Device Proprietary Names: | Geistlich Mucograft®<br>Geistlich Mucograft® Seal |
|---------------------------|---------------------------------------------------|
| Common or Usual Name: | Collagen Matrix |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification | II |

#### III. Predicate Device

Substantial equivalence is claimed to the following devices:

| Product Name | 510(k) | Applicant |
|------------------------------------------|---------|---------------------|
| Geistlich Mucograft® and Mucograft® Seal | K192042 | Geistlich Pharma AG |
| | K140518 | Geistlich Pharma AG |
| | K102531 | Geistlich Pharma AG |
| | K073711 | Geistlich Pharma AG |

#### IV. Device Description

Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration. The matrices are made of collagen without further cross-linking. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of

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collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.

The products are provided as follows:

- Geistlich Mucograft®: 15 x 20 mm, 20 x 30 mm, and 30 x 40 mm ●
- . Geistlich Mucograft® Seal: 8 mm and 12 mm diameter

#### V. Indications for Use

Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for:

- covering of implants placed in immediate or delayed extraction sockets;
- localized gingival augmentation to increase keratinized tissue (KT) around teeth and ● implants;
- alveolar ridge reconstruction for prosthetic treatment; and ●
- recession defects for root coverage. ●

#### VI. Comparison of Technological Characteristics

The Indications for Use Statement is identical to the predicate device.

The subject devices are equivalent to the predicate devices with respect to materials characteristics, manufacturing and sterilization methods, and packaging. Both the subject and predicate devices have identical final product specifications. A comparison of the subject and predicate device is provided in the table below.

| | Subject Devices | Predicate Devices<br>(K192042, K140518,<br>K102531, K073711) | Analysis |
|----------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Porcine collagen | Same | Equivalent |
| Shape | Geistlich Mucograft®:<br>Rectangle<br>Geistlich Mucograft® Seal:<br>Circle | Same | Equivalent |
| Sizes | Geistlich Mucograft®:<br>15 x 20 mm<br>20 x 30 mm<br>30 x 40 mm<br>Geistlich Mucograft® Seal:<br>8 mm diameter<br>12 mm diameter | Geistlich Mucograft®:<br>15 x 20 mm<br>20 x 30 mm<br>30 x 40 mm<br>Geistlich Mucograft® Seal:<br>8 mm diameter | Different. The subject<br>devices include a larger<br>size of Geistlich<br>Mucograft® Seal. The<br>difference in size does<br>not raise different |

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| | Subject Devices | Predicate Devices<br>(K192042, K140518,<br>K102531, K073711) | Analysis |
|---------------|-----------------|--------------------------------------------------------------|------------------------------------------|
| | | | questions of safety or<br>effectiveness. |
| Single-Use | Yes | Same | Equivalent |
| Sterilization | Gamma | Same | Equivalent |

Since prior clearance, the following minor changes were made:

- . addition of a new 12 mm diameter Geistlich Mucograft® Seal configuration, and
- slight changes in the manufacturing processes for intermediate and final products.

These changes do not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.

#### Performance Data VII.

Mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate device was leveraged in support of substantial equivalence.

Based on the results of risk assessment, no additional testing was required to support the new size configurations.

## VIII. Conclusion

The subject devices are identical to the predicate device. The addition of a new 12 mm diameter for Geistlich Mucograft® Seal and slight changes in the manufacturing processes for the final product does not raise different questions of safety and effectiveness as demonstrated by risk assessment and verification and validation testing. Therefore, it is concluded that Geistlich Mucograft® and Geistlich Mucograft® Seal are substantially equivalent to the identified predicate devices.

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