(109 days)
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants
- 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.
The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.
The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
This document is a 510(k) summary for the DSM Biomedical Porcine Pericardium Dental Membrane, seeking substantial equivalence to a predicate device (Bio-Gide® K042197).
The provided text does not contain detailed acceptance criteria or a study design in the format typically used for evaluating the performance of AI/ML-based medical devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating the substantial equivalence of a physical medical device (a resorbable membrane) to a predicate device.
However, I can extract the relevant information from the document to answer your questions based on the type of device and study described.
Here's the breakdown of the "acceptance criteria" and "study" as presented in this context:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly that the subject device (DSM Biomedical Porcine Pericardium Dental Membrane) performs similarly or equivalently to the predicate device (Bio-Gide®) across various characteristics, including in vivo performance.
The reported device performance is that the subject device achieved similar new bone formation to the predicate device in an animal model, even with faster degradation.
| Characteristic | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Indications for Use | Equivalent to Bio-Gide® | Indicated for simultaneous use of GBR-membrane and implants, augmentation around implants, localized ridge augmentation, alveolar ridge reconstruction, filling of bone defects, guided bone regeneration in dehiscence defects, guided tissue regeneration procedures in periodontal defects. |
| Material Composition | Similar to Bio-Gide® (Porcine Pericardium-derived extracellular matrix vs. Purified porcine collagen) | Porcine Pericardium-derived extracellular matrix |
| Form | Resorbable lyophilized membrane (similar to Bio-Gide®) | Resorbable lyophilized membrane |
| Size Offerings | Multiple sizes offered (comparable to Bio-Gide®) | 15 mm x 25 mm, 20 mm x 30 mm, 30 mm x 40 mm |
| Operating Principles | Cell-Occlusive, Implantable, Resorbable, Biocompatible (similar to Bio-Gide®) | Cell-Occlusive, Implantable, Resorbable, Biocompatible |
| Reusability | Single use only (similar to Bio-Gide®) | Single use only |
| Packaging | Double pouch (different from Bio-Gide®'s double blister, but still sterile barrier) | Double pouch |
| Non-Pyrogenic | Yes (similar to Bio-Gide®) | Yes |
| Sterility | Sterile, SAL 10-6 (similar to Bio-Gide®) | Sterile, SAL 10-6 |
| Sterilization Method | Ethylene Oxide (different from Bio-Gide®'s Gamma Irradiation, assessed for safety and equivalence) | Ethylene Oxide |
| Shelf Life | 6 months (different from Bio-Gide®'s 36 months, but acknowledged and accepted) | 6 months |
| Micro-architecture | Comparable to Bio-Gide® (similarly sized pores) | Comparable matrix of similarly sized pores |
| Suture Strength | Comparable to Bio-Gide® (suture tear resistance strength) | Maintains suture tear resistance strength |
| In vivo performance (New Bone Formation) | Similar new bone formation as Bio-Gide® in an intrabony defect model | Demonstrated similar new bone formation based on histopathology evaluations. |
| In vivo performance (Degradation) | Degradation profile acceptable and not questioning equivalence (Bio-Gide® degrades slower) | Faster degradation than the predicate, but "does not present questions of equivalence" based on clinical observation and extent of bone regeneration. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility, Subacute Systemic Toxicity, Chronic Systemic Toxicity, Genotoxicity) | All tests Pass according to ISO 10993-1, ISO 10993-3, ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11. | All tests (L929 Neutral Red Uptake, Kligman MZT, Intradermal Injection, Systemic Injection, Rabbit Pyrogen Test, Hemolysis, 28-Day Systemic Toxicity in Rats, 26-Week Systemic Toxicity in Rats, S. Typhimurium and E. Coli Reverse Mutation Assay, Chromosomal Aberration, Rodent Blood Micronucleus Assay) passed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (In vivo animal study): "A canine intrabony defect animal study" was performed.
- Sample Size: Not explicitly stated as a number of animals or defects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective), but it is an in vivo animal study, which is prospective by nature. The origin of the animals for the device material itself is the "United States of America."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth for In vivo Study: The ground truth for the animal study (new bone formation) was established through "histopathology evaluations."
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, but implied to be pathologists or histologists capable of evaluating tissue samples for new bone formation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified. It's likely that histopathology evaluations are conducted by a single qualified expert unless discrepancies arise, at which point an internal expert consensus or review might be employed.
5. 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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical barrier membrane, not an AI/ML diagnostic software. The comparison was device-to-device (subject device vs. predicate device) in an animal model, not AI vs. human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth Type: For the in vivo animal study, the ground truth for evaluating new bone formation was established by histopathology evaluations.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "characterization" and "bench tests" are akin to pre-market testing for a physical product, not machine learning model training.
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable, as there is no training set for an AI/ML model for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2016
Kensey Nash Corporation Dba DSM Biomedical Brianna Schehr Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19431
Re: K160474
Trade/Device Name: DSM Biomedical Porcine Pericardium Dental Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: May 19, 2016 Received: May 19, 2016
Dear Ms. Brianna Schehr:
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. 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.
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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K160474
Device Name
DSM Biomedical Porcine Pericardium Dental Membrane
Indications for Use (Describe)
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants
- 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)
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Image /page/3/Picture/1 description: The image shows the DSM company logo. The logo consists of a colorful abstract swirl on the left and the letters "DSM" in blue on the right. The swirl is made up of different colors, including blue, green, yellow, and pink. The letters "DSM" are in a bold, sans-serif font.
510(k) Summary
| Submitted By: | DSM Biomedical |
|---|---|
| 735 Pennsylvania Drive | |
| Exton, PA 19341 | |
| Contact Person: | Brianna Schehr |
| brianna.schehr@dsm.com | |
| (P) 484-713-2100 | |
| (F) 484-713-2806 | |
| Date Prepared: | June 5, 2016 |
| Device: | |
| Trade Name: | DSM Biomedical Porcine Pericardium Dental Membrane |
| Common/Usual Name: | Porcine Derived Collagen Dental Membrane |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Bone Grafting Material |
| Regulatory Class: | II |
| Product Code: | NPL (Barrier, Animal Source, Intraoral) |
| Advisory Panel: | Dental |
| Predicate Device: | Bio-Gide® (K042197) [Geistlich-Pharma] |
Device Description:
The DSM Biomedical Porcine Pericardium Dental Membrane is a resorbable porcine pericardium derived extracellular matrix barrier membrane for guided tissue and bone regeneration in dental applications. The device is manufactured using a standardized, controlled, multistage process. The origin of all animals is the United States of America. It is provided as a lyophilized sheet in sizes 15 mm x 25 mm, 20 mm x 30 mm, and 30 mm x 40 mm, which may be hydrated with saline or blood. It can be easily trimmed or shaped to the appropriate size to fit the defect to be treated. When hydrated, the membrane is easily drapeable while maintaining suture tear resistance. It is supplied sterile by ethylene oxide and is for single use only.
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Image /page/4/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, composed of overlapping shapes in shades of blue, green, purple, and orange. To the right of the swirl is the company's name, "DSM," in bold, blue letters.
The DSM Biomedical Porcine Pericardium Dental Membrane functions as a barrier when applied between bone graft material and soft tissue. The membrane serves as a bioresorbable scaffold that is eventually remodeled, resorbed, and replaced by host tissue. Animal studies have shown that DSM Biomedical Porcine Pericardium Dental Membrane is resorbed within 2 to 9 weeks.
Indications For Use:
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for:
- simultaneous use of GBR-membrane and implants;
- 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;
- quided tissue regeneration procedures in periodontal defects.
Basis for Substantial Equivalence:
The DSM Biomedical Porcine Pericardium Dental Membrane is substantially equivalent in terms of indications for use, material composition, technological characteristics, and performance characteristics to the predicate device, Bio-Gide® [Geistlich-Pharma] K042197.
A comparison of DSM Biomedical Porcine Pericardium Dental Membrane and the predicate device supports substantial equivalence based on the design, material, indications for use, technical characteristics, and performance. The technological characteristics of the DSM Biomedical Porcine Pericardium Dental Membrane are equivalent to the predicate device as shown in extensive material and physical characterization testing. The subject and predicate devices are derived from the same animal source, are provided sterile and for single use. Both devices are provided in lyophilized form in multiple size offerings. The micro-architecture is comparable as both contain a matrix of similarly sized
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Image /page/5/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, with petals in shades of blue, green, orange, and purple. To the right of the swirl is the company name, "DSM," in bold, blue letters.
pores. The suture strength is also comparable, as both have suture tear resistance strength to withstand the forces of suturing to maintain positioning during implantation.
The performance of the DSM Biomedical Porcine Pericardium Dental Membrane was evaluated in a canine intrabony defect model compared to the predicate device. The study showed that coverage of dental bone defects with the subject device or predicate device results in similar new bone formation based on histopathology evaluations. The subject device degraded faster than the predicate, but based on clinical observation and extent of bone regeneration, this faster degradation does not present questions of equivalence.
| Characteristic | DSM Biomedical Porcine PericardiumDental Membrane(Subject Device) | Bio-Gide®(K042197: Predicate Device) |
|---|---|---|
| Indications for Use | DSM Biomedical Dental Bone Graft isindicated for simultaneous use of GBR-membrane and implants;augmentation around implants placedin immediate extraction sockets;augmentation around implants placedin delayed extraction sockets;localized ridge augmentation for laterimplantation; alveolar ridgereconstruction for prosthetictreatment; filling of bone defectsafter root resection, cystectomy,removal of retained teeth; guidedbone regeneration in dehiscencedefects; guided tissue regenerationprocedures in periodontal defects. | Bio-Gide® is indicated forsimultaneous use of GBR-membraneand implants; augmentation aroundimplants placed in immediateextraction sockets; augmentationaround implants placed in delayedextraction sockets; localized ridgeaugmentation for later implantation;alveolar ridge reconstruction forprosthetic treatment; filling of bonedefects after root resection,cystectomy, removal of retainedteeth; guided bone regeneration indehiscence defects; guided tissueregeneration procedures inperiodontal defects. |
| Target Population | Human, oral, periodontal | Human, oral, periodontal |
| Animal Origin | Porcine | Porcine |
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Image /page/6/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful, abstract swirl design on the left, with the letters "DSM" in bold, blue font on the right. The swirl design is made up of several overlapping shapes in different colors, including blue, green, orange, and purple. The overall design is modern and corporate.
| Characteristic | DSM Biomedical Porcine PericardiumDental Membrane(Subject Device) | Bio-Gide®(K042197: Predicate Device) |
|---|---|---|
| MaterialComposition | Porcine Pericardium-derivedextracellular matrix | Purified porcine collagen |
| Form | Resorbable lyophilized membrane | Resorbable lyophilized membrane |
| Sizes | 15 mm x 25 mm, 20 mm x 30 mm, 30mm x 40 mm | 13 mm x 25 mm, 25 mm x 25 mm, 40mm x 50 mm |
| OperatingPrinciples | Cell-OcclusiveImplantableResorbableBiocompatible | Cell-OcclusiveImplantableResorbableBiocompatible |
| Reusable | Single use only | Single use only |
| Packaging | Double pouch | Double blister |
| Non-Pyrogenic | Yes | Yes |
| Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 |
| SterilizationMethod | Ethylene Oxide | Gamma Irradiation |
| Shelf Life | 6 months | 36 months |
Performance Data:
The substantial equivalence of DSM Biomedical Porcine Pericardium Dental Membrane and its predicate was demonstrated based on in vitro characterization studies, biocompatibility studies, in vivo animal studies, and clinical history of the predicate device.
FDA recognized standard ISO 22803 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File, was used to guide the characterization of
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Image /page/7/Picture/1 description: The image shows the logo for DSM, a global science-based company. The logo consists of a colorful, abstract swirl design on the left, with the letters "DSM" in bold, blue font on the right. The swirl design is made up of several overlapping shapes in different colors, including blue, green, orange, and purple. The overall design is modern and eye-catching.
the DSM Biomedical porcine Pericardium Dental Membrane as no applicable performance standards exist for this device.
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device. A series of device characterization and bench tests were conducted which included an evaluation of physical properties such as dimensional analysis, microarchitecture analysis including percent porosity and median pore diameter, and resorption. Evaluation of resorption was performed in a canine intrabony defect model. Material characterization testing of the DSM Biomedical Porcine Pericardium Dental Membrane was completed to evaluate the material properties of the device. Bench testing was completed to verify that the device exhibits drapeability when hydrated, adheres to tissue, and maintains sufficient suture tear resistance strength.
In addition to the in vitro characterization tests, a canine intrabony defect animal study was performed to evaluate membrane degradation and new bone formation following treatment with the DSM Biomedical Porcine Pericardium Dental Membrane compared to the predicate device.
Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Hemocompatibility, Subacute Systemic Toxicity, Chronic Systemic Toxicity, and Implantation. Other testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable.
| Biological Effect | Standard | Test | Result |
|---|---|---|---|
| Cytotoxicity | ISO 10993-5 | L929 Neutral Red Uptake | Pass |
| Sensitization | ISO 10993-10 | Kligman Maximization Test | Pass |
| Irritation | ISO 10993-10 | Intracutaneous Injection | Pass |
| Acute SystemicToxicity | ISO 10993-11 | Systemic Injection TestRabbit Pyrogen Test | Pass |
| Hemocompatibility | ISO 10993-4 | Hemolysis—Rabbit Blood—Indirect Contact | Pass |
| Subacute SystemicToxicity, Implantation | ISO 10993-6ISO 10993-11 | 28-Day Systemic Toxicity in Rats viaIntramuscular and Subcutaneous Implantation | Pass |
19
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Image /page/8/Picture/1 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful, abstract swirl design on the left, with shades of blue, green, orange, and purple. To the right of the swirl is the company's name, "DSM," in bold, blue letters.
| Chronic SystemicToxicity andImplantation | ISO 10993-6ISO 10993-11 | 26-Week Systemic Toxicity in Rats viaSubcutaneous Implantation | Pass |
|---|---|---|---|
| Genotoxicity | ISO 10993-3 | S. Typhimurium and E. Coli Reverse MutationAssay | Pass |
| Chromosomal Aberration | Pass | ||
| Rodent Blood Micronucleus Assay | Pass |
Given the similarities between the DSM Biomedical Porcine Pericardium Dental Membrane and the predicate device, it was determined that clinical data was not necessary to demonstrate substantial equivalence.
Conclusion:
Pursuant to section 510(k), DSM Biomedical Porcine Pericardium Dental Membrane is substantially equivalent to the predicate device Bio-Gide® with regard to indication for use, material, technological characteristics, including principles of operation, and performance characteristics as shown in an anatomically relevant animal model.
§ 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.