(8 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a hydraulic cement, with no mention of AI or ML.
Yes
This device is intended for the repair and sealing of root canals, which are therapeutic interventions to address dental conditions.
No
This device is described as a hydraulic cement-like powder used for repair and sealing within the root canal, promoting cementogenesis. Its performance studies focus on physico-chemical properties and biocompatibility, comparing it to other materials like WHITE MTA. There is no mention of it collecting, analyzing, or interpreting biological data to identify a disease, condition, or risk.
No
The device description clearly states it is a "white hydraulic cement-like powder composed of biocompatible ceramic particles" and is mixed with a liquid. This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (Repair of Root Perforations, Repair of Root Resorption, Root End Filling, Apexification, Pulp capping) are all procedures performed within the body (in vivo) to treat dental conditions.
- Device Description: The description of BioAggregate as a "white hydraulic cement-like powder" that is mixed and forms a "hermetic seal inside the root canal" further confirms its use as a material implanted or used directly within the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples outside the body (in vitro), such as blood, urine, or tissue samples, which is the defining characteristic of an IVD.
Therefore, BioAggregate is a medical device used for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Repair of Root Perforations
Repair of Root Resorption
Root End Filling
Apexification
Pulp capping
Product codes (comma separated list FDA assigned to the subject device)
KIF
Device Description
BioAggregate is a white hydraulic cement-like powder composed of biocompatible ceramic particles. The BioAggregate Powder promotes cementogenesis upon mixing with BioA Liquid and forms a hermetic seal inside the root canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
BioAggregate has undergone extensive bench and biocompatibility testing to provide evidences that BioAggregate's physico-chemical properties are substantially equivalent to WHITE MTA MATERIAL. Bench tests included Working Time, Setting Time, Solubility and Radiopacity. Biocompatibility tests results determined that BioAggregate is nonmutagenic, non-cytotoxic, does not cause allergenic potential to tissues after multiple uses and has good tolerance by subcutaneous tissues. BioAggregate has the same indications for use, includes similar materials and comparable technological characteristics as WHITE MTA MATERIAL. In addition, the bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. The chemical compounds of BioAggregate that were not equivalent to MTA were found to be safe and effective in Tantalum Beads - Radiographic Marker, Synthes (USA) chronOSTM and PerioGlas - Bioglass Bone Graft Particulate. Therefore, it is concluded that BioAggregate is safe, effective and substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011009, K010348, K041350, K040278
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters, followed by the letters "IBC" inside of a circle. The address is listed as 3650 Wesbrook Mall, Vancouver, BC V6S 2L2 Canada. The phone number is (604) 221 6800, and the fax number is (604) 677 6129.
510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92
| SUBMITTER: | Innovative BioCeramix Inc.
3650 Wesbrook Mall
Vancouver, BC V6S 2L2 Canada
Tel: 604-221-6800
Fax: 604-677-6129 | NOV 2 1 2006 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT: | Dr. Quanzu Yang | |
| SUMMARY PREPARED: | Jul 25, 2006 | |
| TRADE NAME: | BioAggregate | |
| COMMON NAME: | Root Canal Repair Filling Material | |
| CLASSIFICATION NAME: | Root Canal Filling Resin (21 CFR 872.3820, Product Code: KIF) | |
| PREDICATE DEVICE: | Dentsply International WHITE MTA MATERIAL (K011009) | |
| | For specific chemical compositions:
• Biomet, Inc. Tantalum Beads - Radiographic Marker (K010348)
• Synthes (USA) chronOSTM(K041350)
• NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate
(K040278) | |
| DEVICE DESCRIPTION: | BioAggregate is a white hydraulic cement-like powder composed of
biocompatible ceramic particles. The BioAggregate Powder promotes
cementogenesis upon mixing with BioA Liquid and forms a hermetic seal
inside the root canal. | |
| INTENDED USE: | • Repair of Root Perforations
• Repair of Root Resorption
• Root End Filling
• Apexification
• Pulp capping | |
| TECHNOLOGICAL
CHARACTERISTICS: | BioAggregate is equivalent to WHITE MTA MATERIAL,
in terms of the physical state (powder-liquid mix), working time, setting
time, solubility and radiopacity. Similar major chemical compounds are
utilized in the production of both BioAggregate and WHITE MTA
MATERIAL. Both materials are non-mutagenic and non-cytotoxic, and are
designated for the same indications for use. The primary difference between | |
1
Image /page/1/Picture/0 description: The image shows the logo for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters. Below the company name is the address, 3650 Wesbrook Mall.
Vancouver BC Tel. (604) 221 6800 Fax: (604) 677 6129
the two materials is that BioAggregate has an aluminum-free composition, which contains chemical compounds that improve BioAggregate's properties in terms of safety and effectiveness, and includes calcium phosphate.
The additional predicate devices include: Tantalum Beads - Radiographic Marker, Synthes (USA) chronOS™ and PerioGlas - Bioglass Bone Graft Particulate each containing specific chemical compounds that are equivalent to BioAggregate, providing evidence that these chemical compounds are safe and effective for medical devices use.
NON-CLINICAL TESTS BioAggregate has undergone extensive bench and biocompatibility testing PERFORMED: to provide evidences that BioAggregate's physico-chemical properties are substantially equivalent to WHITE MTA MATERIAL. Bench tests included Working Time, Setting Time, Solubility and Radiopacity. Biocompatibility tests results determined that BioAggregate is nonmutagenic, non-cytotoxic, does not cause allergenic potential to tissues after multiple uses and has good tolerance by subcutaneous tissues.
CONCLUSIONS: BioAggregate has the same indications for use, includes similar materials and comparable technological characteristics as WHITE MTA MATERIAL. In addition, the bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. The chemical compounds of BioAggregate that were not equivalent to MTA were found to be safe and effective in Tantalum Beads - Radiographic Marker, Synthes (USA) chronOSTM and PerioGlas - Bioglass Bone Graft Particulate. Therefore, it is concluded that BioAggregate is safe, effective and substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2006
Innovative Bioceramix Incorporated C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K063422
Trade/Device Name: BioAggregate Regulation Number: 21 CFR 872.3820 Regulation Name: Regulatory Class: II Product Code: KIF Dated: November 10, 2006 Received: November 13, 2006
Dear Mr. Devine:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Senitte y. Michieu Davis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Koballing 510(k) Number (if Known): Device Name: BioAggregate Indications for Use: Repair of Root Perforation . Repair of Root Resorption . Root End Filling . Apexification . Pulp Capping .
ん Prescription Use _ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rump
Page 1 of 1
3.01-4.10) n of Anesthesiology, General Hospital, con Control, Dental Devices
0634122
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