(16 days)
Not Found
No
The summary describes a dental restorative material and does not mention any AI or ML capabilities.
No
The device is a restorative material used for filling dental cavities, not for treating a disease or condition.
No
The device description states it is a "restorative material for use in filling all dental cavity classes," indicating it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "hybrid resin-DEVICE DESCRIPTION: DEVICE DESCREATIve material" and a "direct Composite Testorative maingle paste," indicating it is a physical material, 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 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.
- Device Description: The description clearly states that DYRACT® EXTRA RESTORATIVE is a "hybrid resin-restorative material for use in filling all dental cavity classes." It is a material that is placed directly into a dental cavity.
- Intended Use: The intended use is for filling dental cavities, which is a direct treatment/restoration within the body, not a test performed on a sample outside the body.
The information provided describes a dental restorative material used for direct placement in the mouth, which falls under the category of a dental device, not an IVD.
N/A
Intended Use / Indications for Use
DYRACT® EXTRA RESTORATIVE is indicated for Cavity Classes III, IV, V, and VI . Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal distance.
Product codes
EBF
Device Description
DYRACT® EXTRA RESTORATIVE is a hybrid resin-restorative material for use in filling all dental cavity classes. The direct Composite Testorative maingle paste that is filled into a cavity in increments up to 2 mm before visible light curing.
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)
Dyract® AP Restorative, K973235, Quixx® Posterior Restorative, K040144
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR 2 2 2005
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street. Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | April 1, 2005 |
| TRADE OR PROPRIETARY NAME: | DYRACT® EXTRA RESTORATIVE |
| CLASSIFICATION NAME: | Tooth shade resin material, 872.3690 |
| PREDICATE DEVICES: | Dyract® AP Restorative, K973235 |
| Quixx® Posterior Restorative, K040144 |
DYRACT® EXTRA RESTORATIVE is a hybrid resin-DEVICE DESCRIPTION: DEVICE DESCREATIve material for use in filling all dental cavity classes. The direct Composite Testorative maingle paste that is filled into a cavity in increments up to 2 mm before visible light curing.
INTENDED USE: DYRACT® EXTRA RESTORATIVE is indicated for Cavity Classes III, INTENDED OOE. D'ITCTCTC 21 21 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 11 intercuspal distance.
TECHNOLOGICAL CHARACTERISTICS: All of the components in DYRACT® EXTRA TECHNOLOGICAL CHARACTERREAD IN marketed devices and found to be safe for dental use. NESTORATIVE have been assum rogenents of DYRACT® EXTRA RESTORATIVE in the we believe that the prof and of the support the safety and effectiveness of DYRACT® EXTRA RESTORATIVE for the indicated uses.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the seal.
APR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K050880
Trade/Device Name: Dyract® eXtra Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 04, 2005 Received: April 06, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaiter is substantially equivalent (for the indications for referenced above and nave decimilied the ace need in ess marketed in interstate commerce
use stated in the enclosure) to legally markets of marketed in interesthat use stated in the enclosure) to legally man technique in end mentiments, or to devices that proof to May 28, 1970, the chacinent date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMAA . You may have been reclassified in accordance with the provisions wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval or a prematiconsplay in the Act. The general therefore, market the device, subject to mai general sense par registration, listing of devices, good
controls provisions of the Act include requirements for annial register controls provisions of the Act morade requiritions against misbranding and adulteration.
ﭗ
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) interest major regulations affecting your device can be
may be subject to such additional controls. Existing major regulations FDA ma may be subject to such additions, Title 21, Parts 800 to 899. In addition, FDA may publish found in the Code of I caeral in the Federal Register.
2
Page 2 – Ms. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that PDA S Issualice of a substition with other requirements of the Act or that FDA has made a delemination that your develop other Federal agencies. You must comply with any Federal statules and regulations administered of to: registration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: set forth in t all the Act's requirements, including, but nor incertains as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing procession in the product reading readin labeling (21 CFR Part 801), good manabitant (2) Production (2001), and if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if appli systems (QS) regulation (21-531-542 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 ocgin manceing your arrial equivalence of your device to a legally premarket nothcation. The PDA Intentify of baosanian organ
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 If you desire specific advice for your do note the regulation of the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the office of contact the Office of Compulance at (210) 270 of 10.17 PM Part 807.97). You may obtain other
"Misbranding by reference to premarket notification' (21 CFR Part Division of Sw "Misbranding by relefence to premail.cricans.com the Act from the Division of Small
general information on your responsibilities under the Act from the Universe (800) 6 general international on your responsionnes assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collsaner Floram. For and Consistencial of Collection of Chindex.html.
Sincerely yours,
Suite y. Mahieu MD.
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
3
INDICATIONS FOR USE STATEMENT
ﻢ
510(K) Number (if known):
Device Name:
DYRACT® EXTRA RESTORATIVE
Indications for Use:
Premarket Notification
Indicated for
- Cavity Classes III, IV, V, and VI .
- Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal ● distance
Prescription Use __X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
7
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Supa Ramsey
wision Sign-Off) vision of Anesthesiology, General Hospital, mection Control, Dental Devices
Number: 1903082
DYRACT® EXTRA RESTORATIVE