(66 days)
M0176, K051463
No
The description focuses on the chemical and physical properties of a dental adhesive and does not mention any computational or algorithmic components.
No
Explanation: This device is an adhesive used for dental restorations, not for treating or diagnosing a medical condition.
No
The device is a bonding agent used in dental restorations, not for diagnosing conditions.
No
The device description clearly indicates it is a physical substance (adhesive) offered in bottles and blisters, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Futurabond M/Futurabond M Single Dose is a dental adhesive used to bond filling materials to tooth structure. It is applied directly to the tooth and does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its function in direct and indirect dental restorations, cavity sealing, and treating exposed root surfaces. These are all procedures performed directly on the patient's tooth.
Therefore, Futurabond M/Futurabond M Single Dose falls under the category of a dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
- Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes.
- Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
- Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces
- Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.
Product codes
KLE
Device Description
Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch-bond reinforced with nano-particles to build a durable bond between tooth substance and light-curing filling materials without marginal leakage.
Futurabond M/Futurabond M Single Dose displays the same adhesive properties of totaletch preparations without separate etching of the tooth substance.
Futurabond M/Futurabond M Single Dose tolerates residual moisture.
Futurabond M/Futurabond M Single Dose is an all-purpose adhesive for use with all lightcuring composites, compomers and Ormocer®s.
Futurabond M/Futurabond M Single Dose is offered in 5 ml plastic bottles (Futurabond M) and in 0.06 ml Single Dose blisters (Futurabond M Single Dose).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth substance, cavity, root surfaces
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
M0176, K051463
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
Г
្រី
Image /page/0/Picture/1 description: The image shows four black shapes arranged horizontally. The first shape is a triangle with a rectangle cut out of the top. The second shape is a circle with a smaller circle cut out of the center. The third shape is a circle with a C-shaped cut out of the side. The fourth shape is a circle with a smaller circle cut out of the center, similar to the second shape.
Anton-Flettner-Straße 1 - 3 27472 Cuxhaven · Germany
િ +49 4721 719-0
್ಕೆ 04721 719-109 +49 4721 719-140
NOV 24 2008
www.voco.de info@@voco.de
ﮯ۔
ﺎ
Ihr Zeichen yr. ref.
Ihre Nachricht vorn did.
VOCQ GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany
Unser Zeichen our ref.
Datum date
510(k) SUMMARY
Manfred Th. Plaumann
Contact:
September 10, 2008 Date prepared:
Futurabond M/Futurabond M Single Dose Trade or proprietary name:
Agent, Tooth Bonding Resin (872.3200) Classification name:
| Predicate devices: | Clearfil S³Bond | K042913 |
|---|---|---|
| Predicate devices: | Clearfil S³Bond Single Dose | K051796 |
Device description: Futurabond M/Futurabond M Single Dose is a single-component, light-curing, self-etch-bond reinforced with nano-particles to build a durable bond between tooth substance and light-curing filling materials without marginal leakage.
Futurabond M/Futurabond M Single Dose displays the same adhesive properties of totaletch preparations without separate etching of the tooth substance.
Futurabond M/Futurabond M Single Dose tolerates residual moisture.
Futurabond M/Futurabond M Single Dose is an all-purpose adhesive for use with all lightcuring composites, compomers and Ormocer®s.
Futurabond M/Futurabond M Single Dose is offered in 5 ml plastic bottles (Futurabond M) and in 0.06 ml Single Dose blisters (Futurabond M Single Dose).
Intended use:
- Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes,
- Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
- Futurabond M/Futurabond M Single Dose is also suited for the treatment of . exposed root surfaces
- Futurabond M/Futurabond M Single Dose can be used for core build-ups using . light-cured or dual-cured filling materials.
Geschältslüher: Martied Plaunan, Martied Thonas Plaunan, Olaf Sauerbier / Antsgericht Tosted HFB 110134 - Eritillungson und Gerichtsstand: Cushaven Stadisparkasse Cuxhaven (BLZ 241 500 01) 149690 · IBAN: DE942415000100001496900 BIC: BHLMDE21CUX
1
Technological characteristics: All of the components of Futurabond M/Futurabond M Single Dose are found in the legally marketed devices K042913 (Clearfil S3Bond), M0176 (Clearfil S Bond Single Dose) and K051463 (Xeno Adhesive with Activator) Futurabond M and Futurabond M Single Dose are identical in composition and performance characteristics.
The prior use of all of the components of Futurabond M/Futurabond M Single Dose in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.
We believe that the prior use of the components of Futurabond M/Futurabond M Single Dose in legally marketed devices and the performance data and results provided support the safety and effectiveness of Futurabond M/Futurabond M Single Dose for the intended use.
VOCO GmbH September 10, 2008
GMBIF
Manfred Th. Plaumanion-Flettner-Str. 1-3
(Managing Board) 27472 CUXHAVEN
Germany
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Thorsten Gerkensmeier VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven, Germany D- 27472 NOV 2 4 2008
Re: K082753
Trade/Device Name: Futurabond M/Furabond M Single Dose Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 17, 2008 Received: September 19, 2008
Dear Dr. Gerkensmeier:
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 - Dr. Gerkensmeier
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other seneral 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.
Smite Y. Michael Dms.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
1087753 510(k) Number:
Device Name: Futurabond M/Futurabond M Single Dose
Indications for Use:
- Futurabond M/Futurabond M Single Dose is suited as adhesive for direct restoration with light-curing filling materials in all cavity classes.
- Futurabond M/Futurabond M Single Dose is also suited for cavity sealing as a pretreatment for indirect restorations
- Futurabond M/Futurabond M Single Dose is also suited for the treatment of exposed root surfaces
- Futurabond M/Futurabond M Single Dose can be used for core build-ups using light-cured or dual-cured filling materials.
Prescription Use
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: IC082753