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-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, and
guided tissue regeneration procedures in periodontal teeth.

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-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; and
guided bone regeneration in dehiscence defects.

Geistlich Combi-Kit Collagen:
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).

Geistlich Perio-System Combi-Pack:
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).

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® 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. Pre-formed 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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Geistlich Bio-Gide family of devices.

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed de novo device performance study with specific acceptance criteria and detailed clinical outcomes for a novel device. As such, direct "acceptance criteria" and "device performance" in a quantitative sense (like sensitivity/specificity targets) for a new algorithm are not explicitly stated in this type of document. Instead, the "acceptance criteria" here are implicitly meeting the performance characteristics and indications for use of the predicate device, backed by non-clinical and clinical data on the predicate.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Predicate Equivalence)	Reported Device Performance (Leveraged from Predicate Studies)
Material characteristics equivalent to predicate.	Identical (Porcine collagen)
Manufacturing and sterilization methods equivalent to predicate.	Identical (Gamma sterilization)
Packaging and size equivalent to predicate.	Similar sizes for Bio-Gide; identical for Bio-Gide Shape, Bio-Gide Compressed, Bio-Gide Perio, Combi-Kit Collagen, and Perio-System Combi-Pack
Biocompatibility in accordance with ISO 10993-2018.	Leveraged from predicate (K192042), indicating compliance.
Sterilization effectiveness (SAL) in accordance with ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2017.	Leveraged from predicate (K192042), indicating compliance.
Shelf-life stability equivalent to predicate.	Leveraged from predicate (K192042), indicating stability.
Similar bench performance to predicate.	Leveraged from predicate (K192042), implying similar performance.
Clinical performance for various dental defect types (e.g., bone growth, defect size reduction, alveolar ridge preservation).	"Complete wound closure is not required when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls." (Based on 15 clinical studies involving 297 unique patients).

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 297 unique patients across 15 clinical studies.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be historical clinical studies from the applicant's predicate devices (K192042), making them retrospective in nature for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. Given that the studies involved "evaluation for new bone growth and defect size" and "alveolar ridge preservation," the evaluations were likely performed by dental or oral surgery professionals, but their specific number or qualifications are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the 510(k) summary.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This is a medical device submission for a physical bone grafting material/membrane, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth appears to be clinical outcomes data from human patients, including measurements of new bone growth, defect size reduction, and alveolar ridge preservation. These outcomes would have been evaluated by clinicians, potentially by consensus or standardized measurement protocols, but the specifics are not detailed.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "performance data" section leveraged historical clinical studies from the predicate device as evidence of safety and effectiveness for the subject device.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

4/5/2022

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

Re: K212463

Trade/Device Name: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL. NPM Dated: February 1, 2022 Received: February 1, 2022

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 Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K212463

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)
-------------------------------------------------	--

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.

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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) K212463

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)
-------------------------------------------------	--

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.

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) K212463

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)
-------------------------------------------------	--

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.

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) K212463

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)
-------------------------------------------------	--

Prescription 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.

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) K212463

Device Name

Geistlich Combi-Kit Collagen

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.

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) K212463

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.

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) 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: April 5, 2022

II. Device

Device Proprietary Name:	Geistlich Bio-Gide®
Common or Usual Name:	Resorbable Bilayer Membrane for Guided Tissue and BoneRegeneration
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:

Geistlich Bio-Gide®, K192042, Geistlich Pharma AG ●

IV. Device Description

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Geistlich Bio-Gide® is provided in the following sizes:

. 13 x 25 mm
25 x 25 mm
30 x 40 mm
40 x 50 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.

VI. Comparison of Technological Characteristics

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

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

Technological comparison

	Subject Device	Geistlich Bio-Gide®(K192042)	Analysis
Material	Porcine collagen	Identical	The material ofconstruction isidentical.
Sizes	13 x 25 mm25 x 25 mm30 x 40 mm40 x 50 mm16 x 22 mm	Substantially equivalent	The offered sizes aresimilar.
Single-Use	Yes	Identical	Both products aresingle-use only.
Sterilization	Gamma	Identical	Both products usegamma irradiation.

{10}------------------------------------------------

The purpose of this submission is to notify the Agency of several minor changes to the product labeling and extension of the product range to include a 30 x 40 mm configuration which falls within the range of size configurations cleared under the predicate device. The differences between the subject and predicate device are addressed by the information provided within this submission.

VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling or extension to the product line.

Results from biocompatibility, sterilization, shelf-life, and bench and clinical performance studies from the applicant's own predicate devices (K192042) was leveraged in support of substantial equivalence. The following standards were utilized:

ISO 10993-2018 ●
ISO 11137-1:2006 ●
ISO 11137-2:2013
ISO 11137-3:2017

Data from fifteen (15) clinical studies involving 297 unique patients covering conditions from dehiscence type defects at dental implant sites to extraction sockets with and without bone resorption support that complete wound closure is not required for Geistlich Bio-Gide® when used in extraction sites and alveolar ridge defects with an average vertical defect length and alveolar ridge width up to 5.7 mm and 18 mm, respectively. In many of these studies, the defect was filled with bovine bone mineral before being covered with the collagen membrane under study. After a period of time, the defects were evaluated for new bone growth and defect size. Time to evaluation ranged from 4 months to 10 years, with 4 months being the most common length of time examined. The Bio-Gide collagen membrane successfully performed its intended function by creating space to allow for vertical bone fill to occur and providing better alveolar ridge preservation compared to controls.

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® is substantially equivalent to the identified predicate device.

{11}------------------------------------------------

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: April 5, 2022

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Shape
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen 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:

Geistlich Bio-Gide® Shape, K192042, Geistlich Pharma AG ●

IV. Device Description

The Geistlich Bio-Gide® Shape membrane has a pre-shaped form with a maximum width and height of 14 mm x 24 mm, respectively.

{12}------------------------------------------------

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; and
guided bone regeneration in dehiscence defects.

Comparison of Technological Characteristics VI.

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

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

	Subject Device	Geistlich Bio-Gide®Shape(K192042)	Analysis
Material	Porcine collagen	Identical	The material ofconstruction isidentical.
Sizes	14 x 24 mm (pre-shaped)	Identical	The offered sizes areidentical.
Single-Use	Yes	Identical	Both products aresingle-use only.
Sterilization	Gamma	Identical	Both products usegamma irradiation.

oical 1 T

The purpose of this submission is to notify the Agency of several minor changes to the product labeling. The differences between the subject and predicate device are addressed by the information provided within this submission.

are

{13}------------------------------------------------

VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling.

ISO 10993-2018 ●
ISO 11137-1:2006
ISO 11137-2:2013
ISO 11137-3:2017

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Shape is substantially equivalent to the identified predicate device.

---------This space intentionally left blank----------

{14}------------------------------------------------

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: April 5, 2022

II. Device

Device Proprietary Name:	Geistlich Bio-Gide® Compressed
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen 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:

Geistlich Bio-Gide® Compressed, K192042, Geistlich Pharma AG ●

IV. Device Description

The Geistlich Bio-Gide® Compressed membrane is available in two different sizes, 13 x 25 mm and 20 x 30 mm.

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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, and
. guided tissue regeneration procedures in periodontal teeth.

Comparison of Technological Characteristics VI.

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

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

	Subject Device	Geistlich Bio-Gide®Compressed(K192042)	Analysis
Material	Porcine collagen	Identical	The material ofconstruction is identical.
Sizes	13 x 25 mm20 x 30 mm	Identical	The offered sizes areidentical.
Single-Use	Yes	Identical	Both products aresingle-use only.
Sterilization	Gamma	Identical	Both products usegamma irradiation.

Technological comparison

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VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling.

ISO 10993-2018 ●
ISO 11137-1:2006
ISO 11137-2:2013
ISO 11137-3:2017

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Compressed is substantially equivalent to the identified predicate device.

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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: April 5, 2022

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

III. Predicate Device

Substantial equivalence is claimed to the following device:

Geistlich Bio-Gide® Perio, K192042, Geistlich Pharma AG ●

IV. Device Description

Pre-formed 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.

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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.

Comparison of Technological Characteristics VI.

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

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

	Subject Device	Geistlich Bio-Gide®Perio(K192042)	Analysis
Material	Porcine collagen	Identical	The material of construction is identical.
Sizes	16 x 22 mm	Identical	The offered sizes are identical.
Single-Use	Yes	Identical	Both products are single-use only.
Sterilization	Gamma	Identical	Both products use gamma irradiation.

Technological comparison

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VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling.

ISO 10993-2018 ●
ISO 11137-1:2006
ISO 11137-2:2013
ISO 11137-3:2017

VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Bio-Gide® Perio is substantially equivalent to the identified predicate device.

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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: April 5, 2022

II. Device

Device Proprietary Name:	Geistlich Combi-Kit Collagen
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen 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 device:

Geistlich Combi-Kit Collagen, K192042, Geistlich Pharma AG ●

IV. Device Description

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

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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.

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.

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).

VI. Comparison of Technological Characteristics

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

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

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	Subject Device	Predicate Device(K192042)	Analysis
Format	Convenience Kit	Identical	Both products areconvenience kits.
Kit Contents	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide®	Identical	The contents of the kitsare identical.
Sizes	Geistlich Bio-Gide®: 16 x 22 mm	Identical	The product sizes areidentical.
Single-Use	Yes	Identical	Both products aresingle-use only.
Sterilization	Gamma	Identical	Both products aregamma sterilized.

VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling.

ISO 10993-2018
ISO 11137-1:2006
ISO 11137-2:2013 ●
ISO 11137-3:2017 ●

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VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Combi-Kit Collagen is substantially equivalent to the identified predicate device.

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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: April 5, 2022

II. Device

Device Proprietary Name:	Geistlich Perio-System Combi Pack
Common or Usual Name:	Collagen Resorbable Bilayer MembraneCollagen 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:

Geistlich Perio-System Combi Pack, K192042, Geistlich Pharma AG ●

IV. Device Description

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

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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.

Indications for Use V.

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).

VI. Comparison of Technological Characteristics

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

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	Subject Device	Predicate Device(K192042)	Analysis
Format	Convenience Kit	Identical	Both products areconvenience kits.
Kit Contents	Geistlich Bio-Oss Collagen®Geistlich Bio-Gide® Perio	Identical	The contents of thekits are identical.
Sizes	Geistlich Bio-Gide® Perio: 16 x 22 mm	Identical	The product sizes areidentical.
Single-Use	Yes	Identical	Both products aresingle-use only.
Sterilization	Gamma	Identical	Both products aregamma sterilized.

VII. Performance Data

Non-clinical data was not deemed necessary to support the changes to the product labeling.

ISO 10993-2018 ●
. ISO 11137-1:2006
ISO 11137-2:2013 ●
ISO 11137-3:2017 ●

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VIII. Conclusion

The subject device is equivalent to the predicate device with respect to intended use and technological characteristics. Therefore, it is concluded that Geistlich Perio-System Combi-Pack is substantially equivalent to the identified predicate device.

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Regulation Number and Section

§ 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.