VENUS FLOW

K033665 · Heraeus Kulzer, Inc. · EBF · Dec 30, 2003 · Dental

Device Facts

• Record ID: K033665
• Device Name: VENUS FLOW
• Applicant: Heraeus Kulzer, Inc.
• Product Code: EBF · Dental
• Decision Date: Dec 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

Venus Flow is a flowable, light-curing, radiopaque hybrid composite dental material. Used by dentists for various restorative procedures including cavity lining, fissure sealing, Class I-V fillings, splinting, and bracket retention. Applied directly to tooth structure or restorative surfaces in a clinical setting. Provides low viscosity for coverage of tooth structure; cured via light activation. Benefits include aesthetic tooth-colored restoration and structural support for dental repairs.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flowable, light-curing, radiopaque hybrid composite resin. Designed for dental restorative applications. Class II device under 21 CFR 872.3690.

Indications for Use

Indicated for adhesive, tooth-colored anterior and posterior restorations, including Class I, II, III, and V fillings, fissure sealing, cavity lining, splinting, bracket retention, and repair of restorative materials in patients requiring dental restoration.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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## 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 [phone]. Additionally, for questions on the promotion comact the Office of Compinates as contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 | <div>✓</div> | OR | Over-The-Counter Use |
|----------------------|--------------|----|----------------------|
| (Per 21 CFR 801.109) | | | |

(Optional Format 1-2-96)