Bonalive Maxillofacial
Device Facts
| Record ID | K253883 |
|---|---|
| Device Name | Bonalive Maxillofacial |
| Applicant | Bonalive , Ltd. |
| Product Code | LYC · Dental |
| Decision Date | May 14, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.3930 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Bonalive® Maxillofacial is a sterile medical device consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct bony defects. Bonalive® Maxillofacial is indicated for use in the maxillofacial area.
Device Story
Bonalive® Maxillofacial is a synthetic, osteoconductive bone grafting material composed of bioactive glass (S53P4) granules (SiO2, Na2O, CaO, P2O5). The device is used by clinicians in the maxillofacial area to fill, augment, or reconstruct bony defects. Upon implantation, the glass leaches ions into body fluids, forming a silica-gel layer that facilitates calcium phosphate precipitation and crystallization into hydroxyapatite. This process enables chemical bonding to surrounding bone and promotes new bone formation. The material is radiodense, allowing for postoperative radiologic evaluation, and is slowly resorbed and replaced by bone over years. The device is provided sterile via irradiation and is intended for single-use only.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 11137), and shelf-life validation (ISO 11607).
Technological Characteristics
Material: Bioactive glass S53P4 (SiO2, Na2O, CaO, P2O5). Form: Amorphous, non-porous random-shaped granules (0.5-0.8 mm, 1.0-2.0 mm). Principle: Synthetic osteoconductive, ion-leaching, hydroxyapatite formation. Sterilization: Gamma irradiation (SAL 10^-6). Shelf life: 5 years. Radiodense.
Indications for Use
Indicated for patients requiring filling, augmentation, or reconstruction of bony defects in the maxillofacial area.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Bonalive Granules and Bonalive Plates (K070055)
Reference Devices
- BonAlive Granules (K191274)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
Bonalive, Ltd.
% Elisa Maldonado-Holmertz
RA/QA Consultant
Obelix Consulting
806 Jefferson St.
Bastrop, Texas 78602
May 14, 2026
Re: K253883
Trade/Device Name: Bonalive Maxillofacial
Regulation Number: 21 CFR 872.3930
Regulation Name: Bone Grafting Material
Regulatory Class: Class II
Product Code: LYC
Dated: April 9, 2026
Received: April 13, 2026
Dear Elisa Maldonado-Holmertz:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253883 - Elisa Maldonado-Holmertz
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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(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-devices/device-advice-comprehensive-regulatory-assistance/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
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253883 | |
| Device Name Bonalive® Maxillofacial | |
| Indications for Use (Describe) Bonalive® Maxillofacial is a sterile medical device consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct bony defects. Bonalive® Maxillofacial is indicated for use in the maxillofacial area. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
Special 510(k) Summary
K253883
1. Submission Sponsor
Jenna Saarimäki
Regulatory Manager
Bonalive Ltd
Biolinja 2
20750 Turku
Finland
Email: jenna.saarimaki@bonalive.com
Tel number: +358 40 177 4400
2. Submission Correspondent
Obelix Consulting, LLC
806 Jefferson St
Bastrop, TX 787602
USA
Elisa Maldonado-Holmertz
RA/QA Consultant
Email: elisamh@obelixconsult.com
Tel number: 512-431-6069
3. Date Prepared
11 May 2026
4. Device Identification
Type of 510(k) Submission: Special 510(k)
Trade or Proprietary Name: Bonalive® Maxillofacial
Device Description: Bone grafting material, synthetic
Regulation Classification: 872.3930
Product Code: LYC
Class of Device: Class II
Review Panel: Dental
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
Reason for Submission: Process Change (Sterilization), Packaging Change (applicator, sterile barrier) and Labeling Change (Company Name, Product Name, Removal of "cranio" from indication for use).
Predicate: K070055 Bonalive Granules and Bonalive Plates by Vivoxid Ltd.
Prior Related Submission: K191274 Bonalive Granules (Exact same device as the subject device however, different product code and indication for use)
Multiple Devices: None; this is the only device in this submission
## 5. Legally Marketed Predicate Device(s)
Predicate: K070055 Bonalive Granules and Bonalive Plates by Vivoxid Ltd.
Reference: K191274 BonAlive Granules by Bonalive Biomaterials, Ltd.
## 6. Device Description
Bonalive® Maxillofacial is composed of calcium-phosphorous-sodium-silicate (glass S53P4) granules and is a sterile medical device. This synthetic, osteoconductive material is comprised of $\mathrm{SiO}_2$, $\mathrm{Na}_2\mathrm{O}$, CaO and $\mathrm{P}_2\mathrm{O}_5$. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area.
In aqueous solution (e.g. body fluids), bioactive glass works by leaching out ions and developing a silica-gel layer which acts as a template for a calcium phosphate (CaP) precipitation. The CaP crystallizes to hydroxyapatite, which resembles the mineral phase of natural bone in its chemical composition and structure, thus enabling bonding of the bioactive glass to the surrounding bone.
Bonalive® Maxillofacial resorb and is slowly replaced with bone over a period of years. Bonalive® Maxillofacial is radiodense thus enabling postoperative radiologic evaluation.
Best results are obtained by ensuring close contact of the device with surrounding bone tissue and by carefully following the Instructions for Use.
Bonalive® Maxillofacial is sterilized by irradiation and is available in different granule and unit sizes.
## 7. Indication for Use Statement
Bonalive® Maxillofacial is a sterile medical device consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct bony defects. Bonalive® Maxillofacial is indicated for use in the maxillofacial area.
For Rx Use
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
# 8. Substantial Equivalence Discussion
The following table compares the subject device to the predicate with respect to intended use, technological characteristics, and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
Table – Comparison of Characteristics
| Manufacturer | SUBJECT Bonalive Ltd | PREDICATE Vivoxid Ltd (now called Bonalive Ltd) | SIGNIFICANT DIFFERENCES |
| --- | --- | --- | --- |
| Trade Name | Bonalive® Maxillofacial | Bonalive Granules and Bonalive Plates | |
| 510(k) Number | K253883 | K070055 | NA |
| Product Code | LYC | LYC | None |
| Regulation Number | 872.3930 | 872.3930 | None |
| Device Name | Bone grafting material, synthetic | Bone grafting material, synthetic | None |
| Indications for Use | Bonalive® Maxillofacial is a sterile medical device consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct bony defects. Bonalive® Maxillofacial is indicated for use in the maxillofacial area. | Bonalive™ Granules are sterile medical devices consisting of bioactive glass. Bioactive glass is a bone grafting material that is intended to fill, augment or reconstruct periodontal or bony defects. BonAlive™ Granules are indicated for use in the craniomaxillofacial area including jaws. | Removal of “cranio”. Dental bone grafting materials are not indicated for anatomical regions outside the maxillofacial region. |
| Rx or OTC | Rx | Rx | None |
| Physical Form | Amorphous, non-porous random-shaped particles | Amorphous, non-porous random-shaped particles | None |
| Color | Brown | Slightly pink | Color is different and does not impact substantial equivalence. The color change is a result of the new sterilization method - dry heat does not elicit a |
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
| Manufacturer | SUBJECT Bonalive Ltd | PREDICATE Vivoxid Ltd (now called Bonalive Ltd) | SIGNIFICANT DIFERENCES |
| --- | --- | --- | --- |
| Trade Name | Bonalive® Maxillofacial | Bonalive Granules and Bonalive Plates | |
| | | | color change, while gamma irradiation does. |
| Materials Composition | SiO_{2}, Na_{2}O, CaO and P_{2}O_{5} | SiO_{2}, Na_{2}O, CaO and P_{2}O_{5} | None |
| Product Sizes & Shapes | Granule sizes: 0.5-0.8 mm 1.0-2.0 mm | Granules sizes: 0.5-0.8 mm 1.0-2.0 2.0-3.15 mm | Largest granule size 2.0- 3.15 mm is obsolete and does not impact substantial equivalence. |
| | Product volumes: 1 cc 2.5 cc 5 cc 10 cc | Product volumes: 1 cc 2 cc 4 cc 16 cc | Volumes are different and do not impact substantial equivalence. |
| Biocompatibility | Biocompatible ISO 10993 series Addition of an Applicator | Biocompatible ISO 10993 series | None Biocompatibility of the applicator was assessed by the ISO 10993 series in the reference device K191274. Can be assessed by a well-established method (i.e. ISO 10993 series) |
| Sterilization | Gamma Sterile, SAL 10^{-6} | Dry Heat | Different Sterilization method. Gamma sterilization validation was performed per the ISO 11137 series in the reference device K191274. Gamma sterilization validation can be assessed by a well- established method (i.e. ISO 11137 series) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | None |
| Single Use/ | Single use only | Single use only | None |
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
| Manufacturer | SUBJECT Bonalive Ltd | PREDICATE Vivoxid Ltd (now called Bonalive Ltd) | SIGNIFICANT DIFFERENCES |
| --- | --- | --- | --- |
| Trade Name | Bonalive® Maxillofacial | Bonalive Granules and Bonalive Plates | |
| Reuse | | | |
| Mode of action | Works by leaching out ions that react with the body fluids transforming the glass surface chemically into one that by its chemical composition and structure resembles the mineral phase found in natural bone. | Works by leaching out ions that react with the body fluids transforming the glass surface chemically into one that by its chemical composition and structure resembles the mineral phase found in natural bone. | None |
| Properties | Synthetic Osteoconductive | Synthetic Osteoconductive | None |
| Shelf Life | 5 years ISO 11607 | 3 years ISO 11607 | Extended shelf life does not impact substantial equivalence. The method to assess shelf-life is the same as was employed in the predicate. In addition, the 5-year shelf-life was validated in reference device K191274. Shelf life can be assessed by a well-established method (i.e. ISO 11607 series) |
# Summary
Bonalive® Maxillofacial and the predicate device K070055 Bonalive Granules have the same technological characteristics (i.e., design, material, chemical composition, principle of operation, critical specifications (i.e., crystallinity, porosity, dissolution/solubility)) and the same intended use, with the exclusion of "cranio".
The Process Change (Gamma sterilization validation assessed by a well-established method, i.e. ISO 11137 series), Packaging Change (Applicator assessed by a well-established method, i.e. ISO
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Bonalive Ltd
Special 510(k) Premarket Submission
Bonalive® Maxillofacial
10993 series, and a new sterile barrier) and Labeling Change (Company Name, Product Name, Removal of "cranio" from indication for use, and Extended Shelf Life assessed by a well-established method, i.e. ISO 11607) do not impact substantial equivalence.
## 9. Statement of Substantial Equivalence
A subject device is substantially equivalent to a predicate device when the subject device has the same intended use (with the deletion of "cranio") and the same technological characteristics as the previously cleared predicate device, and that the new subject device does not raise different questions regarding its safety and effectiveness as compared to the predicate device. Bonalive® Maxillofacial is substantially equivalent to its predicate.
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