(37 days)
For Metal Supported restorations with conventional cementation
For Metal Supported restorations using SR Adoro Thermo Guard
- Veneering of metal supported restorations using SR Adoro Thermon CRA Adoro
- Veneering of metal supported restorations using ON Pincho Station Thermo Guard
- Veneering of combined dentures (e.g. telescope veneers) using SFA Adoro Thermo Guard
- Veneering of combined dentares (e.g. Ichoope veng SR Adoro Thermo Guardina
Veneering of partially removable implant superstructures using SPAArco - Veneering of partially removable implant superstructures using SF Adoro Themo Guard Guard
- Fabrication of Iong-term temporaries using SR Adoro Thermo Guard
- Fabrication of forig-tenn tomporanes with SR Adoro Opaquer Pink.
For Metal-Free restorations
With Adhesive Cementation: - Inlays/Onlays/Veneers
- Anterior crowns without Vectris framework
- Anterior orowns with Vectrist framework
- Antenor and posterior Crowns was will Wectris framework
- 3-unit antenor and positis framework
With Conventional Cementation :
Conventional Cementation . - long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
- For removable prosthetics
For removable prostnetics - Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adolo layering material.
- Surface characterization with SR Adoro layering material.
- Shade and shape modifications of Ivociar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "SR Adoro®". It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended uses and contraindications.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study from the provided text.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2004
Ms. Donna Marie Hartnett, Esq. Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst. New York 14228
Re: K040951
Trade/Device Name: SR Adoro® Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG and EBF Dated: April 05, 2004 Received: April 12, 2004
Dear Ms. Hartnett:
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 vour 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. Donna Marie Hartnett, Esq.
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International 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,
Chiu S. Lin, PhD
Chiu S. Lin, PhL 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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Indications for Use
510(k) Number (if known): K040951
Device Name: SR ADORO
Indications For Use:
For Metal Supported restorations with conventional cementation
For Metal Supported restorations using SR Adoro Thermo Guard
-
Veneering of metal supported restorations using SR Adoro Thermon CRA Adoro
-
Veneering of metal supported restorations using ON Pincho Station Thermo Guard
-
Veneering of combined dentures (e.g. telescope veneers) using SFA Adoro Thermo Guard
-
Veneering of combined dentares (e.g. Ichoope veng SR Adoro Thermo Guardina
Veneering of partially removable implant superstructures using SPAArco -
Veneering of partially removable implant superstructures using SF Adoro Themo
Guard Guard
-
Fabrication of Iong-term temporaries using SR Adoro Thermo Guard
-
Fabrication of forig-tenn tomporanes with SR Adoro Opaquer Pink.
For Metal-Free restorations
With Adhesive Cementation:
- Inlays/Onlays/Veneers
- Anterior crowns without Vectris framework
- Anterior orowns with Vectrist framework
- Antenor and posterior Crowns was will Wectris framework
- 3-unit antenor and positis framework
With Conventional Cementation :
Conventional Cementation .
-
long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
-
For removable prosthetics
For removable prostnetics -
Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must - Surface characterization with SR Adoro layering material.
subsequently be covered with SR Adolo layering material.
- Shade and shape modifications of Ivociar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
Contraindications:
Contraindications.
-
Veneering of metal support restorations without using SR Adoro Thermo Guard
-
Veneering of metal support restorations maridges in conjunction with Vectris
-
4- and multiple-unlt antenework support (e.g. alloys, Vectris)
-
Cantilever or extension bridges with Vectris
-
Cantilevel of extension bridges with Vectris framework per quadrant
-
More than 4 SR Adolo veheers with voor by the remaining tooth structure
Rehabilitation of quadrants without sufficient support by the remains of the -
Rehabilitation of quadrants without sumclent support by the remainly the sufficient support by the remaining tooth structure
remaining tooth structure
-
Veneering of other metal-free frameworks fabricated of materials other than Vectris
-
Conventional cementation of fixed metal free restorations
-
Conventional cementation of theat free restor in of rooter than 12 months
Long-term metal free temporaries intended for a wear period of honger than 12 months -
Long-tent metal free temperations or parafunctions, such as bruxism, etc.
Prescription Use ✓ AND/OR
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CPRH, Office of Device Evaluation (ODE) Page 1 of 1 Super Jurna
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: k04095
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.