(39 days)
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None
No
The summary describes a denture acrylic resin and does not mention any AI or ML capabilities.
No
PalaImpact is a material used for the fabrication of dental prosthetics, not a device intended to treat or cure a disease or condition.
No
The device is described as a denture acrylic resin for fabrication of dentures and prosthetic devices, which are therapeutic/restorative in nature, not diagnostic.
No
The device is described as a heat curing, high-impact denture acrylic resin, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PalaImpact is a denture acrylic resin used for fabricating dentures and prosthetic devices. This is a material used in the body or for creating devices that go in the body, not for testing samples from the body to diagnose conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, PalaImpact falls under the category of a medical device used for fabrication and prosthetics, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PalaImpact is a heat curing, high-impact denture acrylic resin for the fabrication and repair of full and partial dentures. PalaImpact is also used for fixed and removable prosthetics devices.
Product codes
EBI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2005
Ms. Cheryl V. Zimmerman Director, Quality Operations and Compliance Heraeus Kulzer, Incorporated 4315 South Lafayette Boulevard South Bend, Indiana 46614
Re: K043504
Trade/Device Name: Palaimpact® Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 15, 2004 Received: December 30, 2004
Dear Ms. Zimmerman:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your Section 910(x) premained is substantially equivalent (for the ndications for as assemares referenced above and nave accemined the as not is eate devices marketed in interstate commerce use stated in the enclosure) to legally manical Device Amendments, or to devices that proof to May 28, 1970, the chaomism and 61 the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the provise approval application (PMA). The garges therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to the general secure and registration, list in the register on confors provisions of the netude requibitions against misbranding and adulteration.
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) this enames regulations affecting your device can be may be subject to such additions. Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of I caeries in the Federal Register.
1
Page 2 – Ms. Cheryl V. Zimmerman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's Issualice of a substinate equires with other requirements of the Act or that FDA has made a determination that your accuration of the Federal associes. You must comply with
any Federal statutes and regulations administered by other Federal on CE any Federal statutes and regulations administered by ther restration and listing (21 CFR Part 807),
all the Act's requirements, including, but not limited to: registration th all the Act's requirements, including put not innited to: requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as see labeling (21 CFR Part 801); good manufacturing production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applied 100 100 systems (QS) regulation (21 CF 1-542 of the Act); 21 CFR 1000-1050.
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) This letter will allow you to oegill makemig your article equivalence of your device to a legally premarket notification. The PDA midnig of sacomman or 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
rs of the many of the 10, 2019 11: All any alsos note the requiried If you desire specific advice for your de not our s. Also, please note the regulation entitled, a contact the Utfice of Compilance at (240) 210 of 1979. You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Birgion of Small "Misbranding by reference to premailities under the Act from the Division of Small general information on your responsibilities and at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toldsmanain html Manufacturers, International and Consultive Noww.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chris S. Liem, Ph.D.
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
2
Indications for Use
1104 3504 510(k) Number (if known):
Palaimpact Device Name:
Indications for Use: PalaImpact is a heat curing, high-impact denture acrylic resin for Thatications for USC. Transpact to a new casing, again is also used for fixed and removable prosthetics devices.
Prescription Use V 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 CDRH, Office of Device Evaluation (ODE)
Susan Bunner
KO43504
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number _
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