(298 days)
No
The device description and performance studies focus on the material properties and biological interactions of a synthetic bone graft, with no mention of AI or ML.
Yes
The device is intended for augmenting alveolar bone in tooth extraction procedures and is progressively resorbed and replaced by new bone tissue during the healing process, indicating a therapeutic function.
No
This device is a bone graft substitute intended for augmenting alveolar bone in tooth extraction procedures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Synthetic Bone Graft Particulate" made from "45S5 bioactive glass" in "particulate form," which is a physical material, not software. The performance studies also focus on material properties and biological interactions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states that this device is a "Synthetic Bone Graft Particulate" intended to be "applied to the defect" (an extraction socket in the mouth). It is a material that is placed into the body to aid in bone regeneration.
- Intended Use: The intended use is to "augment the alveolar bone in tooth extraction procedures." This is a surgical procedure performed on the body.
The device is a medical device used in vivo (within the living body) for a therapeutic purpose (bone regeneration), not an IVD used in vitro for diagnostic testing.
N/A
Intended Use / Indications for Use
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
Product codes
LYC
Device Description
Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.
The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.
It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier package (Tyvek-sealed PETG box). The device packages are protected by carboard box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Alveolar bone, tooth extraction sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical tests were performed on the proposed device.
Sterilization complies with ISO 11137. Product shelf-life testing was evaluated to ensure the labeled shelf life. Assessment of biocompatibility was completed per ISO 10993-1. The evaluation included cytotoxicity per ISO 10993-5, sensitization per ISO 10993-10, irritation per ISO 10993-23, pyrogenicity per USP and ISO 10993-11, acute systemic toxicity per ISO 10993-11, subchronic systemic toxicity per ISO 10993-11 and ISO 10993-6, implantation per ISO 10993-6, and genotoxicity per ISO 10993-3. Chemical composition and crystallinity testing were completed per ASTM F1538-03. Morphology testing was completed per ISO 9276-6. Particle size distribution testing was completed per USP. pH value testing was completed per USP. Bioactivity testing was completed per ISO 23317. Water solubility testing was completed per OECD Test No. 105. The FT-IR method was utilized to analyze the additive residue. Bacterial endotoxin testing was performed using the LAL test method, following the USP Bacterial Endotoxins Test, and met the limits (
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Shenzhen Dazhou Medical Technology Co., Ltd. February 21, 2025 % Mandy Li Regulatory Affair Cosmos Biomed Consulting Co., Ltd. Room 1201, No.1, 188 Alley, Shuangliu Road Changning District Shanghai City, CHINA
Re: K241186
Trade/Device Name: Synthetic Bone Graft Particulate Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: April 26, 2024 Received: January 21, 2025
Dear Mandy Li:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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Page
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For comprehensive regulatory information about mediation-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,
Sherrill Lathrop Blitzer
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
3
Indications for Use
510(k) Number (if known) K241186
Device Name Synthetic Bone Graft Particulate
Indications for Use (Describe)
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
| 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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510(k) SUMMARY
1. Submission Information
| Submitter: | Shenzhen Dazhou Medical Technology Co., Ltd.
Suite B605, Building No.1, YESUN INTELLIGENT COMMUNITY II,
1301-76 Guanguang Rd., Longhua District, Shenzhen, Guangdong,
518110, P.R. China |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter contact: | Dr. Jingzhou Yang
Tel: +86-755-21077756
E-mail: yangjingzhou@dazhoumedical.com |
| Date of preparation: | February 21, 2025 |
2. Device Name and Classification
| Product Name: | Synthetic Bone Graft Particulate |
|---|---|
| Classification Name: | Bone Grafting Material, Synthetic |
| Common or Usual Name: | Bone grafting material |
| Regulation Number: | 21 CFR 872.3930 |
| Product Code: | LYC |
3. Predicate Device(s)
| Product Name: | PerioGlas - Bioglass Bone Graft Particulate
(K040278) |
|-----------------------|----------------------------------------------------------|
| Common or Usual Name: | Bone grafting material |
| Regulation Number: | 21 CFR 872.3930 |
| Product Code: | LYC |
4. Device Description
Synthetic Bone Graft Particulate is a synthetic absorbable osteoconductive bone graft substitute manufactured from 45S5 bioactive glass. The device is in particulate form with a size range of 0.5 mm to 1 mm.
The device is intended for augmenting alveolar bone in tooth extraction procedures. At time of use, the device is mixed with sterile saline to form a wet sandy paste that is applied to the defect. Synthetic Bone Graft Particulate is progressively resorbed and replaced by new bone tissue during the healing process.
It is supplied sterile, packaged in a rubber stopper-sealed glass bottle within a sterile barrier
5
package (Tyvek-sealed PETG box). The device packages are protected by carboard box.
5. Indications for Use
Synthetic Bone Graft Particulate is intended to be used to augment the alveolar bone in tooth extraction procedures. (i.e., use in extraction sockets only)
| Substantial
Equivalence
Comparison | Predicate Device [K040278]
PerioGlas -Bioglass Synthetic Bone
Graft Particulate | Proposed Device
Synthetic Bone Graft Particulate |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
& Product
Code | Class II, LYC | Same as predicate |
| Indications for
Use | PerioGlas – Bioglass Bone Graft
Particulate is indicated to be packed
into bony voids or gaps to fill and/or
augment oral, dental intraosseous, and
craniofacial defects. These defects may
include: periodontal/infrabony defects;
alveolar ridge augmentation
(sinusotomy, osteotomy, cystectomy);
dental extraction sites (ridge
maintenance, implant
preparation/placement); sinus lifts;
cystic defects; craniofacial
augmentation. PerioGlas may be used
alone in a manner comparable to
autogenous bone graft chips or
allograft bone particulate
(demineralized freeze dried bone), or it
may be mixed with either as a bone
graft extender. | Synthetic Bone Graft Particulate is
intended to be used to augment the
alveolar bone in tooth extraction
procedures. (i.e., use in extraction
sockets only) |
| Application | Gently packed into defect sites as non-
structural scaffold for body's natural | Same as predicate |
| Substantial
Equivalence
Comparison | Predicate Device [K040278]
PerioGlas -Bioglass Synthetic Bone
Graft Particulate | Proposed Device
Synthetic Bone Graft Particulate |
| | healing and bone regeneration
processes | |
| Material | Bioactive glass | Same as predicate |
| Morphology | Irregular dense particulate | Same as predicate |
| Particle Size | 90-710 microns | 500-1000 microns |
| Resorption
Rate | Majority absorbed by six months | Same as predicate |
| Mechanical | Particulate material; not intended for
use in load-bearing defects without
proper internal or external fixation | Particulate material; requires an
adequate healing period prior to
load-bearing |
| Performance | Bone infiltration occurs throughout the
grafts site via osteoconduction,
resulting in increased graft site
mechanical stiffness and strength | Bone infiltration occurs throughout
the grafts site |
| Bone
Remodeling | New bone grows into the graft area via
osteoconduction. The material is
slowly absorbed and replaced by the
host bone. | Same as predicate |
6. Comparison to the Predicate Device
6
Synthetic Bone Graft Particulate can be used in the same intended way as PerioGlas, without bone extender materials, and it thus substantially equivalent to PerioGlas for the same indication for use.
The technological characteristics of Synthetic Bone Graft Particulate are similar to the predicate in terms of the device material. Both devices are calcium phospho-silicate inorganic materials. The particle size of Synthetic Bone Graft Particulate is similar to that of PerioGlas. Synthetic Bone Graft Particulate and the predicate are designed to be gently packed into defect sites, functioning as a non-structural scaffold for the body's natural healing and bone regeneration process. The device acts as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow.
7. Performance Data
7
Non-clinical tests were performed on the proposed device.
Sterilization complies with ISO 11137. Product shelf-life testing was evaluated to ensure the labeled shelf life. Assessment of biocompatibility was completed per ISO 10993-1. The evaluation included cytotoxicity per ISO 10993-5, sensitization per ISO 10993-10, irritation per ISO 10993-23, pyrogenicity per USP and ISO 10993-11, acute systemic toxicity per ISO 10993-11, subchronic systemic toxicity per ISO 10993-11 and ISO 10993-6, implantation per ISO 10993-6, and genotoxicity per ISO 10993-3. Chemical composition and crystallinity testing were completed per ASTM F1538-03. Morphology testing was completed per ISO 9276-6. Particle size distribution testing was completed per USP. pH value testing was completed per USP. Bioactivity testing was completed per ISO 23317. Water solubility testing was completed per OECD Test No. 105. The FT-IR method was utilized to analyze the additive residue. Bacterial endotoxin testing was performed using the LAL test method, following the USP Bacterial Endotoxins Test, and met the limits (