(76 days)
Not Found
No
The description details a manual toothbrush with an antimicrobial agent, with no mention of AI or ML capabilities.
No
The device is a manual toothbrush intended to remove plaque and food debris from teeth, and the antimicrobial agent is only to prevent bacterial growth on the brush itself, not to have any therapeutic effect on the user.
No
The device is a manual toothbrush intended for cleaning teeth, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a manual toothbrush with a polymer handle and synthetic bristles, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove plaque and food debris from teeth and to prevent bacterial growth on the toothbrush itself between uses. This is a mechanical action and a surface treatment for the device, not a diagnostic test performed on a sample from the human body.
- Device Description: The description confirms it's a manual toothbrush with antimicrobial bristles. There is no mention of it being used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers
The antimicrobial agent is intended to keep the toothbrush clean, not to diagnose or treat a condition in the user. The predicate devices listed also support this conclusion, as they are a toothbrush and a stethoscope diaphragm, neither of which are IVDs.
N/A
Intended Use / Indications for Use
The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
Product codes
EFW
Device Description
The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
The antimicrobial has been demonstrated to reduce the growth of bacteria and is registered with the United States Environmental Protection Agency as a bacteriostat. The EPA registered the antimicrobial under the manufacturer's name. Sinanen Company, Limited. The manufacturer has issued a Notice of Supplemental Distribution of a Registered Pesticide Product to AgION Technologies, LLC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (implied)
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:
Laboratory studies for plastic bristle fibers containing AgION antimicrobial have shown that the product reduces the growth of bacteria on the surface of the fiber.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
Image /page/0/Picture/1 description: The image shows a handwritten sequence of numbers and letters. The sequence starts with the letters 'KO', followed by the numbers '21383'. The handwriting appears to be somewhat rough or stylized, giving the characters a slightly irregular appearance.
- G. 510(k) Summary of Safety and Effectiveness Information
Company Information:
AgION Technologies, LLC. 60 Audubon Road Wakefield, MA 01880 Tel. 781-224-7106 Fax 781-246-3340 pford(@agion-tech.com
Contact: Paul C. Ford, P.E. Director of Regulatory Affairs
Summary Preparation Date: April 30, 2002
Device Information:
Classification Panel: Dental Devices
Trade Name: Zeodyne Toothbrush with AgION ™ Antimicrobial
Common Name: Toothbrush
Classification Name: Toothbrush, Manual
Regulation Number: 21 CFR § 872.6855
Product Code: EFW
Predicate Device:
| Device Name | Applicant Name | 510(k) Number |
|---|---|---|
| Crest Toothbrush with | ||
| MicroShield | The Proctor & Gamble | |
| Company | K973236 | |
| Disposable Stethoscope | ||
| Diaphragm with AgION | ||
| Antimicrobial | ||
| Compound | Doctor's Research Group | K002047 |
1
Device Description:
The Zeodyne Toothbrush with AgION antimicrobial is a manual toothbrush consisting of a shaft with synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth. The toothbrush contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses, maintaining the cleanliness of the brush.
Intended Use:
The Zeodyne Toothbrush with AgION™ Antimicrobial is intended to remove adherent plaque and food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have any effect on the user.
Technological Characteristics Compared to the Predicate Devices:
But for the antimicrobial additive, the Zeodyne Toothbrush with AgION antimicrobial is composed of handle and bristle materials similar to the Crest toothbrush. Like the Crest Toothbrush with MicroShield, the Zeodyne Toothbrush with AgION antimicrobial contains an antimicrobial agent to prevent the growth of bacteria on the brush between uses. Both the Crest Toothbrush with MicroShield and the Zeodyne Toothbrush with AgION antimicrobial contain an antimicrobial ingredient. While the antimicrobial agents in the two brushes are different, the antimicrobial activity of the Crest antimicrobial brush, which contains a chlorhexidine/zinc oxide antimicrobial is expected to be, at a minimum, comparable to the antimicrobial activity of Zeodyne Toothbrush with AgION antimicrobial which contains silver zeolite.
Conclusions of Non Clinical Tests:
Laboratory studies for plastic bristle fibers containing AgION antimicrobial have shown that the product reduces the growth of bacteria on the surface of the fiber.
2
H. Description
The Zeodyne Toothbrush with AgION antimicrobial consists of a polymer based handle and either Nylon 6-12 or polybutylene terephthalate (PBT) bristles. The bristles contain 0.5% AgION antimicrobial.
The antimicrobial has been demonstrated to reduce the growth of bacteria and is registered with the United States Environmental Protection Agency as a bacteriostat. The EPA registered the antimicrobial under the manufacturer's name. Sinanen Company, Limited. The manufacturer has issued a Notice of Supplemental Distribution of a Registered Pesticide Product to AgION Technologies, LLC. (See Appendix 3 & 4)
The antimicrobial is the distinguishing attribute, which is the basis for this 510(k) notification.
A risk assessment, Evaluation of the Potential Health Risks Associated with Zeomic® Type AJ10D Silver Zeolite A - Impregnated Articles: Toothbrushes and Toys was prepared to support the addition of toothbrushes to the current EPA label. This assessment demonstrates the safety of the product by calculating the exposure and comparing it to the EPA Reference Dose. Exposure is calculated at 2.4 x 10 - which as a percentage of the EPA RfD (5 ug/kg/day) is 0.0005. The full evaluation is provided in Appendix 5.
Argyria is a cosmetic effect in which the skin is discolored; it does not impair body function. Silver is currently used in many home water treatment devices. EPA investigated this effect in establishing the National Secondary Drinking Water Regulations, see Federal Register Vol. 56. No. 20 pp. 3526, 3573-3574 in Appendix 6. The Federal Register notice describes EPA's Derivation of a Cosmetic Reference Dose for silver. The Cosmetic RfD is calculated to be 4.7 ug Ag/kg/day and is significantly greater than the anticipated exposure of 2.4 x 10 3 ug/kg/day. No cosmetic effects are expected from the use of the Zeodyne toothbrush.
Background on the AgION Antimicrobial Compound:
Synthesis of the Antimicrobial:
The AgION antimicrobial additive is manufactured from a solution of aluminum hydroxide and sodium silicate. The zeolite is formed in a highly controlled crystalline process. The powder is then separated and washed to remove any residual electrolytes. The zeolite is then added to the ion exchange solution, which incorporates the Ag, Zn and ammonium. The AgION powder is then separated from the solution and dried before packaging. High purity, media-free milling can be used to reduce the particle size. The entire process is complete in a closed system, through to the drying stage.
3
Compounding:
Incorporation in the Nylon 6-12 or PBT is achieved by first preparing a masterbatch of the polymer. The antimicrobial is compounded into a polymer matrix to yield master batch at a load level of 60% by weight. Preparation of the polymer master batch is carried out with a twin-screw extruder having a Length/Diameter (L/D) ratio of 32:1. The carrier resin is dried to moisture content of 0.010 percent or less using a regenerating desiccant-type, dehumidifying dryer. The extrudate must remain completely free of moisture via an in-line drying system for master batch pellet conditioning.
The antimicrobial, base polymer and master batch must be maintained under conditions of maximum dryness throughout storage, handling (pre- and post process) and material feeding. All feed hoppers and holding bins, including the collection vessel for master batch pellets, are blanketed with dry air.
Packaging / Storage / Shipping:
When master batch compounding is completed, the master batch is immediately sealed in the holding vessel and allowed to cool. The storage has a liner with sealing capability and a Water Vapor Transmission Rate (WVTR) not to exceed 0.000 g/in2/24hr. (e.g. foil-lined, metalized Mylar®), and blanketed with dry air. The masterbatch is stored in a temperature-stable, dry location, between 15-25℃ (60-80°F) and