(179 days)
Not Found
No
The description focuses on traditional CAD/CAM manufacturing techniques for dental crowns and does not mention any AI or ML components.
No.
The device is a core structure for crowns used in prosthetic rehabilitation, which is a restorative rather than therapeutic function.
No.
The device is described as a core structure for crowns used in prosthetic rehabilitation, without any mention of diagnosing medical conditions or diseases.
No
The device description clearly states the device is a physical core superstructure made of lithium disilicate glass-ceramic, manufactured using CAM techniques. While software is used in the design process, the final device is a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fabrication of core structures for crowns to be cemented to natural or artificial tooth abutments for prosthetic rehabilitation. This is a dental prosthetic device, not a diagnostic test.
- Device Description: The description details the material (lithium disilicate glass-ceramic) and the manufacturing process (wax-up or CAD design, CAM manufacturing). This aligns with the description of a dental restoration component.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample from the human body (like blood, urine, or tissue) to provide information about a disease or condition.
IVD devices are specifically designed to perform tests on biological samples to aid in diagnosis, monitoring, or screening. This device's function is purely structural and restorative within the oral cavity.
N/A
Intended Use / Indications for Use
The NobelProcera IPS e.max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.
The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
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)
Non-Clinical Testing: Nobel Biocare has performed mechanical testing of the e.max material including ageing, biaxial (ISO 6872), static, and dynamic load tests to ensure the product will be strong enough to withstand the anticipated mastication forces.
Clinical Testing: Non-clinical test data was used to support the decision of safety and effectiveness.
Conclusions: The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
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.
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
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
Kloos/2
510(k) Summary of Safety and Effectiveness 1.4
AUG 2 0 2010
| Submitted by: | Herbert Crane
Director, Global Requlatory Affairs |
|----------------------------------------|----------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda, CA 92887 |
| Telephone: | (714) 282-5074 |
| Facsimile: | (714) 998-9348 |
| Date of Submission: | February 19, 2010 |
| Classification Name: | Porcelain powder for clinical use (21 CFR 872.6660)
Product code EIH |
| Trade or Proprietary
or Model Name: | NobelProcera IPS e.max Crown |
| Legally Marketed Device(s): | Procera Copings and Pontic (K032562)
IPS e.max CAD/IPS e.max Zircad (K051705) |
Device Description:
イン
NobelProcera IPS e.max CAD Crowns are core superstructures intended for the fabrication of crowns. They are made of lithium disilicate glass-ceramic using a wax-up or CAD design technique.
The Nobel Biocare IPS e.max CAD core superstructure can be designed using traditional wax-up t no nove or using Nobel Biocare crown design software. The core superstructure can be designed using the final anatomic shape or a cut-back technique. Wax-up designs are scanned at the laboratory. Both scanned wax-up and CAD designed core superstructure design information is transmitted electronically to the Nobel Biocare manufacturing facility. The core superstructures are manufactured using CAM techniques and delivered to the laboratory for finishing.
Indications for Use:
The NobelProcera IPS e max Crown is indicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Non-Clinical Testing
Nobel Biocare has performed mechanical testing of the e.max material including ageing, biaxial (ISO 6872), static, and dynamic load tests to ensure the product will be strong enough to withstand the anticipated mastication forces.
Clinical Testing
Non-clinical test data was used to support the decision of safety and effectiveness.
Conclusions
The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.
Nobel Biocare USA Traditional 510(k) Notification NobelProcera IPS e.max Crown February 2010
000015
1
Substantial Equivalence Comparison to Predicate Devices
' ●
| CHARACTERISTIC | CANDIDATE | PREDICATE | PREDICATE |
|---|---|---|---|
| Anatomical Site | Nobel Procera IPS e.max | ||
| Crown | Procera Copings and Pontic | ||
| (K032562) | IPS e.max CAD/IPS e.max Zircad | ||
| (K051705) | |||
| - Oral Cavity | - Oral Cavity | - Oral Cavity | |
| Material | Lithium disilicate ceramic | ||
| (IPS e.max CAD blocks) | Aluminum oxide |
- Zirconium oxide | Lithium disilicate ceramic
- Zirconium oxide |
| Indications for Use | The Nobel Procera IPS e.max
Crown is indicated for use as
core structures of crowns
that will be cemented to
natural or artificial tooth
abutments in the treatment of
partially edentulous patients
as an aid in prosthetic
rehabilitation. | Nobel Biocare's Procera®
Copings and Pontic are indicated
for use as core structures of an
artificial prosthesis, i.e. a three-
unit bridge, for partially
edentulous patients in the need of
prosthetic oral reconstruction in
order to restore chewing function.
The Pontic is indicated as the
core structure of the center unit
and the Copings are indicated as
the core structures of the two side
crowns, thereby forming the
three-unit bridge.
- The Copings are also
indicated for use as single
crowns that will be cemented
to a natural or artificial tooth
abutment in the treatment of
partially edentulous patients
in order to restore chewing
function. | IPS e.max CAD is a CAD/CAM
machinable glass ceramic based
on lithium disilicate for the
preparation of full ceramic
crowns, inlays, onlays, and full
ceramic 3-unit anterior bridges.
IPS e.max ZirCAD consists of
machinable zirconia blocks for
the preparation of full ceramic
crowns, onlays and 3- and 4-unit
bridges and inlay bridges
(anterior and molar). |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nobel Biocare AB C/O Mr. Herbert Crane Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
AUG 2 0 2010
Re: K100512
Trade/Device Name: NobelProcera IPS e.max Crown Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical use Regulatory Class: II Product Code: EIH Dated: July 27, 2010 Received: July 28, 2010
Dear Mr. Crane:
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 ffor 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 mav, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Mr. Crane
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: NobelProcera IPS e.max Crown
Indications For Use:
The NobelProcera IPS e.max Crown isindicated for use as core structures of crowns that will be cemented to natural or artificial tooth abutments in the treatment of partially edentulous patients as an aid in prosthetic rehabilitation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
Kio Muly Cm MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1
510(k) Number: K100512