(518 days)
Ti-oss® is intended for use in dental surgery.
The product is recommended for the following surgeries :
-
Augmentation or reconstructive treatment of alveolar ridge
-
Filling of periodontal defects
-
Filling of defects after root resection, apicoectorny, and cystectorny
-
Filling of extraction sockets to enhance preservation of the alveolar ridge
-
Elevation of maxillary sinus floor
-
Filling of periodontal defects in conjunction with products intended for
Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for
Guided Bone Regeneration
Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
This document is a 510(k) Premarket Notification from the FDA for a medical device called Ti-oss®, a bone grafting material. It is a substantial equivalence determination, meaning the device is deemed equivalent to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner typical of an AI algorithm or a diagnostic tool. Instead, the focus is on demonstrating "substantial equivalence" to a predicate device (OCS-B™) through various physical, chemical, and biological characteristics, as well as intended use and performance.
The document presents a comparison of the Ti-oss® device against its predicate device (OCS-B™) across several items. This serves as the basis for satisfying "acceptance criteria" in the context of a 510(k) submission, where the primary goal is to show the new device is as safe and effective as a legally marketed one.
| ITEM | Ti-oss® (Reported Performance/Characteristics) | OCS-B™ (Predicate Performance/Characteristics) | Compatibility/Similarity Conclusion (Implicit Acceptance) |
|---|---|---|---|
| Intended Use | Intended for use in dental surgery for augmentation/reconstructive treatment of alveolar ridge, filling of periodontal defects, defects after root resection/apicoectomy/cystectomy, extraction sockets, maxillary sinus floor elevation, peri-implant defects (with GTR/GBR products). | Similar intended uses for dental surgery. | Similar: Both devices share the same intended uses and indications for dental surgery. |
| Target Population | Human Oral, Periodontal | Human Oral, Periodontal | Similar: Both are for human oral/periodontal applications. |
| Dosage form | Granules contained in single-use container | Granules contained in single-use container | Similar: Same dosage form and packaging type. |
| Granule sizes | 0,2mm to 1,0mm, 0.5mm to 1.2mm, 1.2mm to 1.7mm | 0.2mm to 1.0mm or 1.0mm to 2.0mm granules | Similar: Both offer a range of sizes that overlap. |
| Material | Anorganic derived osteoconductive hydroxyapatite bone mineral | Anorganic derived osteoconductive hydroxyapatite bone mineral | Similar: Both are made of the same core material. |
| Source bone | Bovine bone | Bovine bone | Similar: Both sourced from bovine bone. |
| Physical Morphology | Trabecular, interconnecting macro and micro pores | Trabecular, interconnecting macro and micro pores | Similar: Both have the same physical structure. |
| Biocompatibility | Appearance Test, Packaging test, Packaging (Dye infiltration test), Dimension (Particle size Test), Weight Test, Ca/P ratio, Crystallinity, Heavy metal, Porosity, Solubility, Extraction, Sterility | Biocompatible (as demonstrated in published literature) | Similar: Ti-oss® tested to confirm biocompatibility, aligning with the predicate's known biocompatibility. |
| Performance | Bone formation (demonstrated through a clinical case series with defect healing and new bone formation sufficient for dental implant placement; histological and radiographic images) | Bone formation (implicit, as a legally marketed bone graft) | Similar: Both are expected to facilitate bone formation as bone graft materials. |
| Compatibility w/other devices | Can be used with GTR membrane | Can be used with GTR membrane | Similar: Both are compatible with GTR membranes. |
| Sterilization Process | Sterile by Gamma irradiation | Sterile by Gamma irradiation | Similar: Both use gamma irradiation for sterilization. |
| Chemical Composition | Similar to predicate based on chemical analysis, XRD, FT-IR and ICP analysis | Similar to based on chemical analysis, XRD, FT-IR and ICP analysis | Similar: Based on detailed chemical analyses, they share similar compositions. |
| Anatomical sites | Oral, Periodontal | Oral, Periodontal | Similar: Both applied to the same anatomical sites. |
| Non-pyrogenic | Yes (Pyrogenicity LAL testing) | Yes | Similar: Both are non-pyrogenic. |
| Shelf life | 2 years (accelerated and real-time shelf life testing) | Determined by Manufacturer (predicate's shelf life assumed acceptable by prior FDA clearance) | Acceptable: Ti-oss® demonstrated a 2-year shelf life, which is acceptable for a bone graft material and likely comparable to the predicate. |
| Risk | Non-risk, as demonstrated by: Virus Clearance study, Analysis of residual solvent, Risk analysis, Cleaning Validation. (Also includes: removal of organic material, product specifications for protein content, viral inactivation study for BHV, BVDV, BPIV, CPV viri, sterility to SAL 1 x 10^-6) | (implicit, as a legally marketed device, its risks are deemed acceptable and controlled) | Acceptable: Ti-oss® has comprehensive risk mitigation demonstrating non-risk, aligning with safety expectations for the predicate. |
Summary of Data Submitted for Ti-oss® (serving as proof of performance against implied criteria):
- Chemical and Physical Characterization (all found comparable to OCS-B™):
- Appearance Test (visual inspection)
- Particle Size test (ISO 3310-1 and particle size distribution)
- Porosity, Pore size distribution, and level of interconnectivity
- Weight Test (gravimetric)
- Structure comparison by SEM
- FT-IR Analysis (USP 29)
- ICP Analysis (ISO 11885)
- XRD Analysis
- Loss on drying test
- pH test (USP 29)
- KMnO4 Volume for Reduction Test
- UV(Ultraviolet) Absorbance Analysis
- Heavy metal test (USP 29)
- Residue on Ignition Test
- Pyrogenicity LAL testing
- Sterility test (USP 29)
- Biocompatibility Tests: Full range recommended in FDA's "Class II, Special Controls Guidance Document: Dental Bone Grafting Devices" and ISO 10993.
- Risk Mitigation: Organic material removal, protein content limits, risk analysis for each production step (cleaning validation, organic solvent removal), viral inactivation study (BHV, BVDV, BPIV, CPV viri).
- Sterility: Achieves a sterility assurance level (SAL) of 1 x 10^-6.
- Shelf Life: Accelerated and real-time shelf life testing according to ASTM F88, ASTM F1140, ASTM F2096, ASTM F1929, and ASTM F1608.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document mentions a "clinical case series" but does not specify a separate "test set" in the context of an algorithm. For evaluating the device's clinical performance, 6 cases were presented in the clinical case series.
- Data Provenance: The document does not explicitly state the country of origin for the clinical cases or whether they were retrospective or prospective. It just lists the details of the 6 cases. Assuming standard clinical practice for such submissions, these would typically be prospective or retrospectively collected cases from clinical use. Given the applicant's address (Republic of Korea), the cases likely originated there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the clinical case series. The "ground truth" seems to be implied by the reported outcomes (defect healing, new bone formation, successful implant placement) based on radiographic and histological evaluation. It's likely that a treating clinician and a histopathologist determined these outcomes.
4. Adjudication method for the test set
- The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus) for the clinical case series.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, where human readers interact with AI. Ti-oss® is a bone grafting material, not an AI or diagnostic device, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. As established, Ti-oss® is a physical medical device (bone grafting material), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the clinical case series, the ground truth was based on outcomes data including:
- Radiographic evaluation: Baseline and various time point radiographs showing defect healing and bone growth.
- Histological evaluation: Core biopsy analysis demonstrating new bone growth.
- Clinical outcome: Capability for dental implant placement after treatment.
8. The sample size for the training set
- There is no mention of a training set because Ti-oss® is not an AI/algorithmic device that requires machine learning training.
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set mentioned 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 5, 2015
Chiyewon c/o Mr. Daniel Nam Pats Corp 4568 W. 1st St. Suite 104 Los Angeles. California 90004
Re: K140021 Trade/Device Name: Ti-oss® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: May 4, 2015 Received: May 5, 2015
Dear Mr. Nam:
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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,
Tina
Kiang -S
for 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)
Device Name
Ti-oss®
Indications for Use (Describe)
Ti-oss® is intended for use in dental surgery.
The product is recommended for the following surgeries :
-
Augmentation or reconstructive treatment of alveolar ridge
-
Filling of periodontal defects
-
Filling of defects after root resection, apicoectorny, and cystectorny
-
Filling of extraction sockets to enhance preservation of the alveolar ridge
-
Elevation of maxillary sinus floor
-
Filling of periodontal defects in conjunction with products intended for
Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for
Guided Bone Regeneration
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
IN CONTROLLER CONSTITUTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
337 Produktion Services (30) 1443 6749
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary
[as required by 807.92(c)]
1. Applicant
CHIYEWON Co., Ltd. 6F., 192, Gyeongchun-ro, Guri-si, Gyeonggi-do, Republic of Korea Phone : 82-31-568-1809 Fax : 82-31-553-3612 Contact : Kim, Sung-O
- Date Prepared : June 4, 2014
3. Device Name and Identification
Proprietary Name : Ti-oss® Device Class : Class II Regulation Number :21 C.F.R. 872.3930 Product Code : NPM Common / Usual Name : Animal Source Dental Bone Grafting Material Classification Name : Bone Grafting Material
4. Predicate Device
SE Number: K113246 Product name: OCS-B™ Company: NIBEC Co., Ltd.
5. Indication for use
Intended for use in dental surgery.
The product is recommended for the following surgeries:
- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
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- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration
6. Device Description
Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.
| Name as per Device Label | Model No. | Brief Description of Item |
|---|---|---|
| Ti-oss®, 0.25g, 0.2-1.0mm | 25-0210 | 0.25g, 0.2-1.0mm particle size, granules in thevial |
| Ti-oss®, 0.5g, 0.2-1.0mm | 05-0210 | 0.5g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 1g, 0.2-1.0mm | 10-0210 | 1g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 2g, 0.2-1.0mm | 20-0210 | 2g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 0.1g, 0.5-1.2mm | 01-0512 | 0.1g, 0.5-1.2 mm particle size, granules in thevial |
| Ti-oss®, 0.25g, 0.5-1.2mm | 25-0512 | 0.25g, 0.5-1.2mm particle size, granules in thevial |
| Ti-oss®, 0.5g, 0.5-1.2mm | 05-0512 | 0.5g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 1g, 0.5-1.2mm | 10-0512 | 1g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 2g, 0.5-1.2mm | 20-0512 | 2g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 0.1g, 1.2-1.7mm | 01-1217 | 0.1g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss®, 0.25g, 1.2-1.7mm | 25-1217 | 0.25g, 1.2-1.7mm particle size, granules in thevial |
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| Ti-oss®, 0.5g, 1.2-1.7mm | 05-1217 | 0.5g, 1.2-1.7mm particle size, granules in the vial |
|---|---|---|
| Ti-oss®, 1g, 1.2-1.7mm | 10-1217 | 1g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss®, 2g, 1.2-1.7mm | 20-1217 | 2g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss® Syringe, 0.25g, 0.5-1.2mm | S25-0512 | 0.25g, 0.5-1.2mm particle size, granules in theSyringe applicator |
| Ti-oss® Syringe, 0.5g, 0.5-1.2mm | S05-0512 | 0.5-1.2mm particle size, , granules in0.5g.Syringe applicator |
| Ti-oss® Syringe, 0.25g, 1.2-1.7mm | S25-1217 | 0.25g, 1.2-1.7mm particle size, granules in theSyringe applicator |
| Ti-oss® Syringe, 0.5g, 1.2-1.7mm | S05-1217 | 0.5g, 1.2-1.7mm particle size, granules in theSyringe applicator |
7. Basis for Substantial Equivalence
Ti-oss® and OCS-B™ have a similar physical and chemical structure. Both are porous, biocompatible bone grafts that facilitate the formation and mineralization of new bone by the osteoblast. As both products have same source of bone (bovine source) and similar process for removal of organic compounds, the product is substantially equivalent to OCS-BTM
The following table summarizes the basis for the Sponsor's substantial equivalence determination:
Substantial Equivalence Comparison
| ITEM | Ti-oss® | OCS-B™ | Compatibilityw/other devices | Can be used with GTR membrane | Can be used with GTR membrane |
|---|---|---|---|---|---|
| Intended Use | Intended for use in dental surgery.The product is recommended for thefollowing surgeries:- Augmentation or reconstructivetreatment of alveolar ridge- Filling of periodontal defects- Filling of defects after root resection,apicoectomy, and cystectomy- Filling of extraction sockets to | OCS-B™ cancellous and corticalgranules are recommended for:- Augmentation or reconstructivetreatment of alveolar ridge- Filling of infrabony periodontaldefects.- Filling of defects after rootresection, apicoectomy, andcystectomy | SterilizationProcess | Sterile by Gamma irradiation | Sterile by Gamma irradiation |
| - enhance preservation of the alveolarridge- Elevation of maxillary sinus floor- Filling of periodontal defects inconjunction with products intended forGuided Tissue Regeneration (GTR)and Guided Bone Regeneration(GBR)- Filling of peri-implant defects inconjunction with products intended forGuided Bone Regeneration | - Filling of extraction sockets toenhance preservation of the alveolarridge- Elevation of maxillary sinus floor- Filling of periodontal defects inconjunction with products intendedfor Guided Tissue Regeneration(GTR) and Guided BoneRegeneration (GBR)- Filling of peri-implant defects inconjunction with products intendedfor Guided Bone Regeneration | ChemicalComposition | Similar to predicate based on chemical analysis, XRD, FT-IR and ICP analysis | Similar to based on chemical analysis, XRD, FT-IR and ICP analysis | |
| Target population | Human Oral, Periodontal | Human Oral, Periodontal | Anatomical sites | Oral, Periodontal | Oral, Periodontal |
| Dosage form | Granules contained in single usecontainer | Granules contained in single usecontainer | Non-pyrogenic | Yes | Yes |
| Granule sizes | 0,2mm to 1,0mm, 0.5mm to 1.2mm,1.2mm to 1.7mm | 0.2mm to 1.0mm or 1.0mm to 2.0mm granules | Shelf life | 2 years | Determined by Manufacturer |
| Material | Anorganic derived osteoconductivehydroxyapatite bone mineral | Anorganic derived osteoconductivehydroxyapatite bone mineral | Risk | Non-risk, as demonstrated by :- Virus Clearance study- Analysis of residual solvent- Risk analysis- Cleaning Validation | - |
| Source bone | Bovine bone | Bovine bone | |||
| PhysicalMorphology | Trabecular, interconnecting macroand micro pores | Trabecular, interconnecting macroand micro pores | |||
| Biocompatibility | □ Appearance Test□ Packaging test□ Packaging (Dye infiltration test)□ Demension (Particle size Test)□ Weight Test□ Ca/P ratio□ Crystallinity□ Heavy metal□ Porosity□ Solubility□ Extraction□ Sterility | Biocompatible (as demonstrated inpublished literature) | |||
| Performance | Bone formation | Bone formation |
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Brief Summary of Data Submitted
The Sponsor evaluated the performance characteristics of Ti-oss® and OCS-B™ with a thorough chemical and physical characterization. The physical and chemical characteristics of the products were found to be comparable as shown in the following:
- Appearance Test by visual inspection ●
- Particle Size test by ISO 3310-1 and particle size distribution ●
- Porosity, Pore size distribution, and level of interconnectivity .
- Weight Test by gravimetric ●
- Structure comparison by SEM ●
- FT-IR Analysis by USP 29 ●
- ICP Analysis by ISO 11885
- XRD Analysis .
- Loss on drying test ●
- pH test by USP 29 ●
- . KMnO4 Volume for Reduction Test
- UV(Ultraviolet) Absorbance Analysis ●
- Heavy metal test by USP 29 ●
- Residue on Ignition Test ●
- Pyrogenicity LAL testing ●
- . Sterility test by USP 29
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In a clinical case series, use of Ti-oss® resulted in defect healing and formation of new bone of sufficient quality to obtain dental implant placement. The patients were treated for intrabony periodontal defects. For each case study, the report includes baseline radiographs, radiographs at various time point, and core biopsy for histological evaluation. Histological and radiographic images demonstrate new bone growth and shown in the table as below.
| Case | Subject | Location | Bone defect type |
|---|---|---|---|
| Case 1 | 61-Y-O-Female | Left Maxillary First, SecondMolar area(operation site : #26,27) | Insufficient alveolar ridgeheight due to significant boneresorption vertically andlaterally |
| Case 2 | 58-Y-O-Female | Right Maxillary First Molararea(operation site : #16) | Insufficient alveolar ridgeheight due to pneumatizationand bone resorption |
| Case 3 | 53-Y-O-Male | Right Maxillary First Molararea(operation site : #16) | Big extraction defect withvertical alveolar boneresorption and insufficientalveolar ridge height |
| Case 4 | 47-Y-O-Female | Right Maxillary First Molararea(operation site : #16) | Significant vertical and lateralbone resorption with nobuccal and lingual wall |
| Case 5 | 57-Y-O-Female | Left Mandibular centralincisor area(operation site : #31) | Significant bone loss on thelingual side of central incisor |
| Case 6 | 47-Y-O-Male | Left Mandibular SecondMolar defect(operation site : #37) | Big extraction defect causedby advance periodontaldisease |
Ti-oss® granules and the application syringe were the subject of the full range of biocompatibility tests recommended in the FDA's "Class II. Special Controls Guidance Document : Dental Bone Grafting Devices" and in accordance with ISO 10993. Organic material has been removed from the product, and product specifications have been established to limit protein content. Throughout the risk analysis for each production step, for example, cleaning validation, the removal of organic solvent, the risk control was conducted during the manufacturing process. A viral inactivation study was conducted for BHV, BVDV, BPIV, and CPV viri. Further, the product is sterilized to achieve a sterility assurance level
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SAL 1 x 10°. Finally, accelerated and real-time shelf life testing was conducted according to ASTM F88, ASTM F1140, ASTM F2096, ASTM F1929, and ASTM F1608.
Based on the information presented herein, it has been demonstrated that Ti-oss is substantially equivalent to OCS-B'M.
Conclusion
The Ti-oss® presents the same types of potential risks to consumers as the predicate device OCS-B™, and has controlled these risks in a similar manner. And biocompatibility tests and compatibility test show that the device meets the requirements of those standards.
Literatures, in vitro chemical and physical characterization tests, and clinical data show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specification and performance.
Therefore, it is concluded that Ti-oss® is substantially equivalent to the predicate device.
§ 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.