(37 days)
Not Found
Not Found
No
The provided text focuses solely on the intended uses and indications for use of dental restoration materials and techniques. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
This device is a dental material used for veneering, fabricating temporaries, and making crowns and prosthetics. It does not appear to treat or prevent a disease or condition, which is characteristic of a therapeutic device.
No
The intended use/indications for use describe the veneering and fabrication of dental restorations and prosthetics, not the diagnosis of medical conditions.
No
The provided text only describes the intended use of a device related to dental restorations and prosthetics. It does not contain any information about the device's components, specifically whether it is software-only or includes hardware. The "Device Description" section is explicitly marked as "Not Found."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to the fabrication and modification of dental restorations and prosthetics (veneers, crowns, temporaries, dentures). These are devices used in the mouth for structural and aesthetic purposes.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The intended uses listed here do not involve testing biological samples.
The device appears to be a dental material or system used by dental professionals for creating and modifying dental appliances.
N/A
Intended Use / 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 Thermo Guard
- Veneering of combined dentures (e.g. telescope veneers) using SR Adoro Thermo Guard
- Veneering of partially removable implant superstructures using SR Adoro Thermo Guard
- Fabrication of long-term temporaries using SR Adoro Thermo Guard
- Fabrication of long-term temporaries with SR Adoro Opaquer Pink.
For Metal-Free restorations
With Adhesive Cementation:
- Inlays/Onlays/Veneers
- Anterior crowns without Vectris framework
- Anterior crowns with Vectris framework
- Anterior and posterior crowns with Vectris framework
- 3-unit anterior and posterior bridges with Vectris framework.
With Conventional Cementation:
- long-term temporaries with Vectris framework for a maximum duration of wear of 12 months.
For removable prosthetics
- Surface characterization of Ivoclar Vivadent denture teeth with SR Adoro Stains. Surfaces must subsequently be covered with SR Adoro layering material.
- Surface characterization with SR Adoro layering material.
- Shade and shape modifications of Ivoclar Vivadent denture teeth with SR Adoro layering material in conjuction with SR Composiv.
Product codes (comma separated list FDA assigned to the subject device)
EBG, EBF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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).
Not Found
§ 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.
0
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.
1
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
2
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