(29 days)
No
The device description and intended use clearly indicate that these are biological materials (collagen membranes and bone mineral) used for tissue regeneration. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on material properties and biological interactions, not computational performance.
Yes
The device, described as surgically implanted, fully resorbable, and intended for oral tissue regeneration, clearly fulfills a therapeutic purpose by facilitating the healing and regeneration of tissues.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that this device is intended for various augmentation, reconstruction, and filling procedures, which are therapeutic in nature. The "Device Description" further elaborates on its composition as a collagen membrane designed for tissue regeneration and support, not for diagnosis.
No
The device description clearly details physical, implantable collagen membranes and bone mineral products, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone and tissue regeneration in the oral cavity. These are therapeutic and reconstructive applications, not diagnostic tests performed in vitro (outside the body) on biological specimens to diagnose diseases or conditions.
- Device Description: The device is described as a collagen membrane or a combination of bone mineral granules and collagen fibers. These are materials designed to be implanted into the body to facilitate healing and regeneration. This is consistent with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), detect specific analytes, or provide diagnostic information.
In summary, the Geistlich Bio-Gide and related products are medical devices intended for surgical use in oral bone and tissue regeneration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
- · augmentation around implants placed in immediate extraction sockets;
- · augmentation around implants placed in delayed extraction sockets;
- · localized ridge augmentation for later implantation;
- · alveolar ridge reconstruction for prosthetic treatment;
- · filling of bone defects after root resection, cystectomy, removal of retained teeth;
- · guided bone regeneration in dehiscence defects; and
- · guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- · augmentation or reconstructive treatment of the alveolar ridge;
- · filling of 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); and
- · filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
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, NPM
Device Description
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Geistlich Bio-Gide® is provided in the following sizes: 13 x 25 mm, 25 x 25 mm, 40 x 50 mm, 16 x 22 mm as part of the Combi-Kit Collagen.
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation. Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm. Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
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 and 20 x 30 mm, Geistlich Mucograft® Seal: 8 mm diameter.
Mentions image processing
Scanning Electron Microscopy (SEM) to assess optical differences
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, alveolar ridge, periodontal defects, bone defects
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)
The following performance studies were conducted on the subject and predicate device to verify that material properties remained unchanged and support the substantial equivalence determination: elongation; suture pull-out test; swelling; Differential Scanning Calorimetry (DSC); collagenase digestion to assess degradation; Scanning Electron Microscopy (SEM) to assess optical differences; and viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050. Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate devices were leveraged in support of substantial equivalence. The subject device is identical to the predicate device. The addition of a raw material supplier does not raise different questions of safety and effectiveness.
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.
K960724, K042197, K050446, K112572, K171643, K112575, K122894, K140518, K102531
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.
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.
0
Image /page/0/Picture/0 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.
August 29, 2019
Geistlich Pharma AG % Roshana Ahmed Associate Director, Regulatory Affairs TELOS Partners LLC 571 Christina Lake Drive Lakeland, Florida 33813
Re: K192042
Trade/Device Name: Geistlich Bio-Gide®, Geistlich Bio-Gide® Shape, Geistlich Bio-Gide® Compressed, Geistlich Bio-Gide® Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft® and Geistlich Mucograft® Seal Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL, NPM Dated: July 31, 2019 Received: July 31, 2019
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 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.
1
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Srinivas Nandkumar, Ph.D. Acting 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
2
510(k) Number (if known)
Device Name
Geistlich Bio-Gide®
Indications for Use (Describe)
Geistlich Bio-Gide® is intended for the following uses:
- · augmentation around implants placed in immediate extraction sockets;
- · augmentation around implants placed in delayed extraction sockets;
- · localized ridge augmentation for later implantation;
- · alveolar ridge reconstruction for prosthetic treatment;
- · filling of bone defects after root resection, cystectomy, removal of retained teeth;
- · guided bone regeneration in dehiscence defects; and
- · guided tissue regeneration procedures in periodontal defects.
Type of Use (Select one or both, as applicable)
| Remediation Use (Part 201, School D) | ☑ |
|---|---|
| Due Care Corrective Use (201, School C) | ☐ |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known)
Device Name
Geistlich Bio-Gide® Shape
Indications for Use (Describe)
Geistlich Bio-Gide® Shape is indicated for:
- · augmentation around implants placed in immediate extraction sockets.
- · augmentation around implants placed in delayed extraction sockets.
- · localized ridge augmentation for later implantation.
- · alveolar ridge reconstruction for prosthetic treatment.
- · filling of bone defects after root resection, cystectomy, removal of retained teeth.
- · guided bone regeneration in dehiscence defects.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known)
Device Name
Geistlich Bio-Gide® Compressed
Indications for Use (Describe)
Geistlich Bio-Gide® Compressed is indicated for:
- · augmentation around implants placed in immediate extraction sockets.
- · augmentation around implants placed in delayed extraction sockets.
- · localized ridge augmentation for later implantation.
- · alveolar ridge reconstruction for prosthetic treatment.
- · filling of bone defects after root resection, cystectomy, removal of retained teeth.
- · guided bone regeneration in dehiscence defects.
- · guided tissue regeneration procedures in periodontal defects.
| Type of Use (Select one or both, as applicable) |
|---|
| Registration Use (Part 21 CFR 801 Subpart D) |
| Over-the-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known)
Device Name
Geistlich Bio-Gide® Perio
Indications for Use (Describe)
Geistlich Bio-Gide® Perio is intended for the following uses:
- · augmentation around implants placed in immediate extraction sockets;
- · augmentation around implants placed in delayed extraction sockets;
- · localized ridge augmentation for later implantation;
- · alveolar ridge reconstruction for prosthetic treatment;
- · filling of bone defects after root resection, cystectomy, removal of retained teeth;
- · guided bone regeneration in dehiscence defects; and
- · guided tissue regeneration procedures in periodontal defects.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known)
Device Name
Geistlich Combi-Kit Collagen
Indications for Use (Describe)
Geistlich Bio-Gide® is intended for the following uses:
- · augmentation around implants placed in immediate extraction sockets;
- · augmentation around implants placed in delayed extraction sockets;
- · localized ridge augmentation for later implantation;
- · alveolar ridge reconstruction for prosthetic treatment;
- · filling of bone defects after root resection, cystectomy, removal of retained teeth;
- · guided bone regeneration in dehiscence defects; and
- · guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- · augmentation or reconstructive treatment of the alveolar ridge;
- · filling of 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); and
· filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known)
Device Name
Geistlich Perio-System Combi-Pack
Indications for Use (Describe)
Geistlich Bio-Gide® Perio is intended for the following uses:
- · augmentation around implants placed in immediate extraction sockets;
- · augmentation around implants placed in delayed extraction sockets;
- · localized ridge augmentation for later implantation;
- · alveolar ridge reconstruction for prosthetic treatment;
- · filling of bone defects after root resection, cystectomy, removal of retained teeth;
- · guided bone regeneration in dehiscence defects; and
- · guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- · augmentation or reconstructive treatment of the alveolar ridge;
- · filling of 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); and
· filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known)
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Summary
Geistlich Bio-Gide®
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® |
|---|---|
| Common or Usual Name: | Resorbable Bilayer Membrane for Guided Tissue and Bone |
| Regeneration | |
| 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 Bio-Gide® | K960724 | Geistlich Pharma AG |
| K042197 | Geistlich Pharma AG | |
| K050446 | Geistlich Pharma AG | |
| K112572 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG ●
10
IV. Device Description
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is provided in the following sizes:
- . 13 x 25 mm
- . 25 x 25 mm
- 40 x 50 mm ●
- 16 x 22 mm as part of the Combi-Kit Collagen .
V. Indications for Use
Geistlich Bio-Gide® is intended for the following uses:
- . augmentation around implants placed in immediate extraction sockets;
- . augmentation around implants placed in delayed extraction sockets;
- . localized ridge augmentation for later implantation;
- . alveolar ridge reconstruction for prosthetic treatment;
- . filling of bone defects after root resection, cystectomy, removal of retained teeth;
- . guided bone regeneration in dehiscence defects; and
- . guided tissue regeneration procedures in periodontal defects.
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device is provided in the table below.
11
| | Subject Device | Predicate Device
(K960724, K042197, K050446,
K112572) |
|---------------|----------------|-------------------------------------------------------------|
| Material | Porcine | Same |
| Sizes | 13 x 25 mm | Same |
| | 25 x 25 mm | |
| | 40 x 50 mm | |
| | 16 x 22 mm | |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
VII. Performance Data
The following performance studies were conducted on the subject and predicate device to verify that material properties remained unchanged and support the substantial equivalence determination:
- elongation; ●
- suture pull-out test; ●
- swelling;
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation; ●
- Scanning Electron Microscopy (SEM) to assess optical differences; and
- viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate devices were leveraged in support of substantial equivalence.
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Bio-Gide® is substantially equivalent to the identified predicate device.
12
Geistlich Bio-Gide® Shape
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Shape |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| 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 Bio-Gide® Shape | K171643 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG ●
IV. Device Description
Geistlich Bio-Gide® Shape is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by
13
gamma irradiation. The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.
V. Indications for Use
Geistlich Bio-Gide® Shape is indicated for:
- . augmentation around implants placed in immediate extraction sockets.
- augmentation around implants placed in delayed extraction sockets. •
- . localized ridge augmentation for later implantation.
- . alveolar ridge reconstruction for prosthetic treatment.
- . filling of bone defects after root resection, cystectomy, removal of retained teeth.
- . guided bone regeneration in dehiscence defects.
Comparison of Technological Characteristics VI.
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device are provided in the table below.
| | Subject Device | Predicate Device
(K171643) |
|---------------|-------------------------|-------------------------------|
| Material | Porcine collagen | Same |
| Sizes | 14 x 24 mm (pre-shaped) | Same |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
14
VII. Performance Data
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test;
- swelling;
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation;
- Scanning Electron Microscopy (SEM) to assess optical differences; and ●
- . viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate device were leveraged in support of substantial equivalence.
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the identified predicate device.
15
Geistlich Bio-Gide® Compressed
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Compressed |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| 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 device:
| Product Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Gio-Gide® Compressed | K171643 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG ●
Device Description IV.
Geistlich Bio-Gide® Compressed is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells into the membrane, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.
16
V. Indications for Use
Geistlich Bio-Gide® Compressed is indicated for:
- . augmentation around implants placed in immediate extraction sockets.
- . augmentation around implants placed in delayed extraction sockets.
- . localized ridge augmentation for later implantation.
- . alveolar ridge reconstruction for prosthetic treatment.
- . filling of bone defects after root resection, cystectomy, removal of retained teeth.
- guided bone regeneration in dehiscence defects.
- guided tissue regeneration procedures in periodontal defects. .
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device is provided in the table below.
| | Subject Device | Predicate Device
(K171643) |
|---------------|------------------|-------------------------------|
| Material | Porcine collagen | Same |
| Sizes | 13 x 25 mm | Same |
| | 20 x 30 mm | |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
Performance Data VII.
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test; ●
- swelling: ●
- Differential Scanning Calorimetry (DSC); ●
17
- collagenase digestion to assess degradation;
- . Scanning Electron Microscopy (SEM) to assess optical differences; and
- viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from ● K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate device were leveraged in support of substantial equivalence.
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the identified predicate device.
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18
Geistlich Bio-Gide® Perio
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Bio-Gide® Perio |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPL |
| Device Classification | II |
Predicate Device III.
Substantial equivalence is claimed to the following devices:
| Product Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Bio-Gide® Perio | K112575 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG
IV. Device Description
Geistlich Bio-Gide® Perio is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
19
Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich BioGide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
V. Indications for Use
Geistlich Bio-Gide® Perio is intended for the following uses:
- . augmentation around implants placed in immediate extraction sockets;
- . augmentation around implants placed in delayed extraction sockets;
- . localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth; .
- guided bone regeneration in dehiscence defects; and ●
- . guided tissue regeneration procedures in periodontal defects.
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device are provided in the table below.
| | Subject Device | Predicate Device
(K112575) |
|---------------|------------------|-------------------------------|
| Material | Porcine collagen | Same |
| Sizes | 16 x 22 mm | Same |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
20
VII. Performance Data
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test;
- swelling;
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation; ●
- Scanning Electron Microscopy (SEM) to assess optical differences; and ●
- . viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate device were leveraged in support of substantial equivalence.
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Bio-Gide® Perio is substantially equivalent to the identified predicate device.
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21
Geistlich Combi-Kit Collagen
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Combi-Kit Collagen |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPM |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
| Product Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Combi-Kit Collagen | K112572 | Geistlich Pharma AG |
| K122894 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG .
22
IV. Device Description
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation.
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation.
The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16 mm x 22 mm.
Indications for Use V.
Geistlich Bio-Gide® is intended for the following uses:
- . augmentation around implants placed in immediate extraction sockets;
- . augmentation around implants placed in delayed extraction sockets;
- . localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment; .
- filling of bone defects after root resection, cystectomy, removal of retained teeth; .
- . guided bone regeneration in dehiscence defects; and
- . guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- . augmentation or reconstructive treatment of the alveolar ridge;
- . filling of 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); and
- . filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
23
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device is provided in the table below.
| | Subject Device | Predicate Device
(K112572 & K122894) |
|---------------|----------------------------------------------------|-----------------------------------------|
| Format | Convenience Kit | Same |
| Kit Contents | Geistlich Bio-Oss Collagen®
Geistlich Bio-Gide® | Same |
| Sizes | Geistlich Bio-Gide®: 16 x 22 mm | Same |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material for the Geistlich Bio-Gide® component of the kit. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
Performance Data VII.
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test;
- swelling; ●
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation;
- Scanning Electron Microscopy (SEM) to assess optical differences; and
- viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate devices were leveraged in support of substantial equivalence.
24
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier for Geistlich Bio-Gide® does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Combi-Kit Collagen is substantially equivalent to the identified predicate device.
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25
Geistlich Perio-System Combi-Pack
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: August 20, 2019
II. Device
| Device Proprietary Name: | Geistlich Perio-System Combi Pack |
|---|---|
| Common or Usual Name: | Collagen Resorbable Bilayer Membrane |
| Collagen Matrix | |
| Classification Name: | Bone Grafting Material |
| Regulation Number: | 872.3930 |
| Product Code: | NPM/NPL |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
| Product Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Perio-System Combi Pack | K112575 | Geistlich Pharma AG |
| K122894 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, Geistlich Pharma AG
IV. Device Description
Geistlich Perio-System Combi-Pack is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide® Perio. Geistlich Bio-Oss Collagen® (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form (100 mg) and is sterilized by gamma irradiation.
26
Geistlich Bio-Gide® Perio (sold either as an individual unit or as one of the components of Geistlich Perio-System Combi-Pack) is a pure collagen membrane with a bilayer structure and smoothed dense (cell-occlusive) surface. The modified surface makes the membrane somewhat stiffer in the dry state, and this facilitates cutting the membrane for periodontal applications. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® Perio bilayer membrane to be provided in the Geistlich Perio-System Combi-Pack convenience kit and as individual units is 16 mm x 22 mm.
Preformed sterile templates are provided to simplify the cutting of the respective membrane shape. Four templates (uncoated Tyvek®) are packaged with Geistlich Bio-Gide® Perio to serve as an aid to assist the clinician in trimming the Geistlich Bio-Gide® Perio membrane to fit the defect, and are in varying shapes to fit the clinical need (e.g., rectangular, interproximal). The templates are packaged as an accessory product with Geistlich Bio-Gide® Perio.
V. Indications for Use
Geistlich Bio-Gide® Perio is intended for the following uses:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation;
- alveolar ridge reconstruction for prosthetic treatment;
- filling of bone defects after root resection, cystectomy, removal of retained teeth;
- . guided bone regeneration in dehiscence defects; and
- . guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- . augmentation or reconstructive treatment of the alveolar ridge;
- . filling of 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); and
- . filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
27
VI. Comparison of Technological Characteristics
The Indications for Use Statement is identical to the predicate device.
The subject device is identical to the predicate device with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate device have identical final product specifications. A comparison of the subject and predicate device are provided in the table below.
| | Subject Device | Predicate Device
(K112575 & K122894) |
|---------------|----------------------------------------------------------|-----------------------------------------|
| Format | Convenience Kit | Same |
| Kit Contents | Geistlich Bio-Oss Collagen®
Geistlich Bio-Gide® Perio | Same |
| Sizes | Geistlich Bio-Gide® Perio: 16 x 22 mm | Same |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material for the Geistlich Bio-Gide® Perio component of the kit. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
Performance Data VII.
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test;
- swelling; ●
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation;
- Scanning Electron Microscopy (SEM) to assess optical differences; and ●
- viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate devices were leveraged in support of substantial equivalence.
28
VIII. Conclusion
The subject device is identical to the predicate device. The addition of a raw material supplier for Geistlich Bio-Gide® does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Perio-System Combi-Pack is substantially equivalent to the identified predicate device.
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29
Geistlich Mucograft® and Geistlich Mucograft® Seal
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: August 20, 2019
II. Device
| Device Proprietary Name: | 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 Name | 510(k) | Applicant |
|---|---|---|
| Geistlich Mucograft® and Mucograft® Seal | K140518 | Geistlich Pharma AG |
| K102531 | Geistlich Pharma AG |
The following device is referenced within the submission:
- Geistlich Fibro-Gide, K171050, 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)
30
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 and 20 x 30 mm ●
- . Geistlich Mucograft® Seal: 8 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. ●
Comparison of Technological Characteristics VI.
The Indications for Use Statement is identical to the predicate device.
The subject devices are identical to the predicate devices with respect to materials characteristics, manufacturing and sterilization methods, packaging, and size. Both the subject and predicate devices have identical final product specifications. A comparison of the subject and predicate device are provided in the table below.
| | Subject Device | Predicate Device
(K140518, K102531) |
|---------------|---------------------------------------------------------------------------------------------------|----------------------------------------|
| Material | Porcine collagen | Same |
| Sizes | Geistlich Mucograft®:
15 x 20 mm and 20 x 30 mm
Geistlich Mucograft® Seal:
8 mm diameter | Same |
| Single-Use | Yes | Same |
| Sterilization | Gamma | Same |
The purpose of this submission is to obtain clearance for the use of an alternate supplier of porcine raw material. This change does not raise different questions of safety and effectiveness and is addressed by the information provided within the submission.
31
The following performance studies were conducted on representative product to verify that material properties remain unchanged and support the substantial equivalence determination:
- elongation;
- suture pull-out test;
- swelling;
- Differential Scanning Calorimetry (DSC);
- collagenase digestion to assess degradation;
- Scanning Electron Microscopy (SEM) to assess optical differences; and
- viral safety evaluation per ICH Q5A(R1) and ISO 22442-3:2007 leveraged from K171050.
Biocompatibility, sterilization, shelf-life, and clinical performance testing from the applicant's own predicate devices were leveraged in support of substantial equivalence.
VIII. Conclusion
The subject devices are identical to the predicate device. The addition of a raw material supplier for Geistlich Mucograft® and Geistlich Mucograft® Seal does not raise different questions of safety and effectiveness. Therefore, it is concluded that Geistlich Mucograft® and Geistlich Mucograft® Seal are substantially equivalent to the identified predicate device.
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