(39 days)
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No
The summary describes a dental composite material and its intended uses, with no mention of AI or ML technology.
No
The device is a restorative material used for fillings and repairs of tooth structure, which is a structural rather than a therapeutic function.
No.
The device is a light-curing, radiopaque hybrid composite used for various types of dental restorations and fillings, which are treatment procedures, not diagnostic ones.
No
The device is described as a "flowable, light curing, radiopaque hyrbrid composite," which is a physical material used for dental restorations, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a material used for restoring teeth (fillings, sealants, etc.). This is a dental restorative material applied directly to the patient's tooth structure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
This device is used on the body, not to test specimens from the body.
N/A
Intended Use / Indications for Use
Venus flow is a flowable, light curing, radiopaque hyrbrid composite used for adhesive, tooth-colored anterior and posterior restorations. Due to its low viscosity Venus Flow provides excellent coverage tooth structure.
Applicable applications includes:
Baseliner in Class I & II cavities; Fissure sealing; Enlarged fissure sealing; Class V fillings; Minimally invasive Class I and II fillings in areas not subjected to masticatory forces; Minimally invasive Class III fillings; Smaller contour and shade adjustment on the enamel and dentine; Small surface repairs to direct and indirect restorative in combination with a suitable bonding agent; Splinting teeth; Cavity lining; Bracket retention; Sealing endodontically treated teeth; Luting porcelain or composite veneers; Filling in voids in temporary crown and bridges materials
Product codes
EBF
Device Description
Venus Flow is a flowable, light curing, radiopaque hybrid composite.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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).
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three wavy lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Ms. Cheryl V. Zimmerman Manager, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K033665
Trade/Device Name: Venus™ Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 19, 2003 Received: November 24, 2003
Dear Ms. Zimmerman:
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.
1
Page 2 – Ms. Cheryl V. Zimmerman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised mate 1 271 b issuate it your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You music any a comply with all 1 coccar statutes and regulated. but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, menuting, value manufacturing practice requirements as set forth in the quality fabeling (21 CFR Part 807), good nart 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) I his letter will anow you to begin finding of substantial equivalence of your device to a legally premaince notification: - The PDF million 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 If you desire spoolite at (301) 594-4613. Additionally, for questions on the promotion comact the Office of Compinates as contact the Office of Compliance at (301) 594-4639. Also, and advertising or your are retired, "Misbranding by reference to premarket notification" (21CFR please note and regulation entitled, r general information on your responsibilities under the Act may I all 807,71,304 they obtain: "Careergeneralianal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cacciatoffa
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1_ 510(k) Number (if Known):
Device Name: Venus Flow
Indications For Use:
Venus flow is a flowable, light curing, radiopaque hyrbrid composite used for adhesive, tooth-colored anterior and posterior restorations. Due to its low viscosity Venus Flow provides excellent coverage tooth structure.
Applicable applications includes:
Baseliner in Class I & II cavities; Fissure sealing; Enlarged fissure sealing; Class V fillings; Minimally invasive Class I and II fillings in areas not subjected to masticatory forces; Minimally invasive Class III fillings; Smaller contour and shade adjustment on the enamel and dentine; Small surface repairs to direct and indirect restorative in combination with a suitable bonding agent; Splinting teeth; Cavity lining; Bracket retention; Sealing endodontically treated teeth; Luting porcelain or composite veneers; Filling in voids in temporary crown and bridges materials
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device evaluation (ODE)
Angela Blackwell for MSK
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K033665 |
|---|---|
| ---------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)