K Number
K210280
Device Name
Geistlich Mucograft®, Geistlich Mucograft® Seal
Date Cleared
2021-03-03

(30 days)

Product Code
Regulation Number
872.3930
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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 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
More Information

Not Found

No
The summary describes a collagen-based resorbable matrix for oral tissue regeneration. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on mechanical testing, biocompatibility, sterilization, shelf-life, and clinical performance of the material itself.

No.
The device is described as a surgically implanted, fully resorbable device intended for oral tissue regeneration, but its indications for use focus on structural augmentation and covering, not on treating a disease or therapeutic condition.

No

This device is a surgical implant designed for oral tissue regeneration and does not state any diagnostic functions.

No

The device description clearly states that the device is a "surgically implanted, fully resorbable device" made of collagen, indicating it is a physical, material-based medical device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes a surgically implanted device for oral tissue regeneration and augmentation. This involves direct interaction with the patient's body for therapeutic purposes.
  • Device Description: The description details a resorbable collagen matrix designed to be surgically implanted to facilitate tissue growth. This is a physical implant, not a device used to test samples from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples from the body (like blood, urine, tissue samples, etc.) to provide diagnostic information. The device's function is to physically support tissue regeneration.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

NPL

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 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192042, K140518, K102531, K073711

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3930 Bone grafting material.

(a)
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.(b)
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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland Phone: +41 41 492 55 55

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

II. Device

| Device Proprietary Names: | Geistlich Mucograft®
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 Name510(k)Applicant
Geistlich Mucograft® and Mucograft® SealK192042Geistlich Pharma AG
K140518Geistlich Pharma AG
K102531Geistlich Pharma AG
K073711Geistlich 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

4

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

5

| | Subject Devices | Predicate Devices
(K192042, K140518,
K102531, K073711) | Analysis |
|---------------|-----------------|--------------------------------------------------------------|------------------------------------------|
| | | | questions of safety or
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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