(141 days)
Sinfony™ Indirect Lab Composite, Paradigm™ MZ100 Block for CEREC®, 3M LVR System Z100™ Restorative, 3M™ ESPE™ HAUR P-10™ Posterior Filling Material
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a preformed composite crown, with no mention of AI or ML.
No
The device is a dental crown used for the restoration of permanent teeth, which is a structural repair rather than a therapeutic treatment for a disease or condition.
No
The device is described as a tooth-colored single unit crown used for the restoration of permanent teeth, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a "preformed composite crown" that is "initially malleable" and "light-cured," indicating it is a physical, material-based device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the 3M TM ESPE™ Adult Crown is a "tooth colored single unit crown for use as a durable restoration for permanent teeth." It is a physical material used to restore a tooth, not a test performed on a sample from the body.
- Intended Use: The intended use is for "restoration of permanent teeth," which is a therapeutic or restorative purpose, not a diagnostic one.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information.
This device is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
3M TM ESPE™ Adult Crown is a tooth colored single unit crown for use as a durable restoration for permanent teeth. This preformed composite crown, manufactured by 3M ESPE, is initially malleable and can be easily customized to the crown preparation by trimming and reshaping. The crown is then light-cured to obtain its high strength and subsequently cemented in place with permanent cement. The entire crown procedure is accomplished in one visit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
permanent teeth
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)
This 510(k) submission includes data from bench testing to evaluate the performance of 3M TM ESPETM Adult Crown compared to predicate devices Paradigm™ MZ100 Block for CEREO® and Sinfony™ Indirect Lab Composite. The properties evaluated include Compressive Strength. Flexural Strength, Flexural Modulus, Depth of cure, Surface Hardness (Barcol), Radiopacity, Water sorption, Water solubility, Diametral Tensile Strength and Sensitivity to Ambient Light. Also included in this submission are the results of an In Vitro Chewing Simulation study comparing 3M ™ ESPE™ Adult Crown and Paradigm™ MZ100 Block for CEREC®.
Based on bench testing conducted, the dinical performance of 3M TM ESPETM Adult Crown is expected to be substantially equivalent to crowns produced using Paradigm™ MZ100 Block for CEREC® and Sinfony TM Indirect Lab Composite.
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.
Sinfony™ Indirect Lab Composite, Paradigm™ MZ100 Block for CEREC®, 3M LVR System Z100™ Restorative, 3M™ ESPE™ HAUR P-10™ Posterior Filling Material
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
§ 872.3690 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
Image /page/0/Picture/13 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is bolded and sans-serif.
FEF | 5 |
510(k) Summary 5.
3M ESPE Dental Products
3M Center St. Paul, MN 55144-1000 651 733 1110
Image /page/0/Picture/6 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is bolded and sans-serif.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510(k) Submitter | 3M Company
3M ESPE Dental Products
3M Center, Bldg. 260-2A-11
St. Paul, MN 55144-1000 USA
Establishment Registration Number: 2110898 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Scott Erickson
Regulatory Affairs Specialist
Phone: (615) 736-9883
Fax: (651) 737-6049
sterickson@mmm.com |
| Date Summary was Prepared | 9/26/07 |
| Trade Name | 3M TM ESPE TM Adult Crown |
| Common Name(s) | Preformed composite crown |
| Recommended Classification | Tooth shade resin material
(21 CFR 872.3690, |
Product Code: EBF)
Predicate Devices: Sinfony™ Indirect Lab Composite Paradigm™ MZ100 Block for CEREC® 3M LVR System Z100™ Restorative, 3M™ ESPE™ HAUR P-10™ Posterior Filling Material
3M ™ ESPE™ Adult Crown 510(k)
1
Image /page/1/Picture/0 description: The image shows the text "3M ESPE" in a bold, sans-serif font. The letters are black against a white background. The text appears to be a logo or brand name.
Description of Device:
3M TM ESPE™ Adult Crown is a tooth colored single unit crown for use as a durable restoration for permanent teeth. This preformed composite crown, manufactured by 3M ESPE, is initially malleable and can be easily customized to the crown preparation by trimming and reshaping. The crown is then light-cured to obtain its high strength and subsequently cemented in place with permanent cement. The entire crown procedure is accomplished in one visit.
Indications for Use:
For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)
Substantial Equivalence:
Information provided in this 510(k) submission shows that 3M ™ ESPE™ Adult Crown is substantially equivalent to the predicate devices in terms indications for use and technology, including product formulation. A biocompatibility assessment was developed for 3M ™ ESPET™ Adult Crown using standard risk assessment techniques and consideration of FDA & internationally recognized quidelines. The conclusion of the assessment is that 3M ESPE Adult Crown is safe for its intended use.
This 510(k) submission includes data from bench testing to evaluate the performance of 3M TM ESPETM Adult Crown compared to predicate devices Paradigm™ MZ100 Block for CEREO® and Sinfony™ Indirect Lab Composite. The properties evaluated include Compressive Strength. Flexural Strength, Flexural Modulus, Depth of cure, Surface Hardness (Barcol), Radiopacity, Water sorption, Water solubility, Diametral Tensile Strength and Sensitivity to Ambient Light. Also included in this submission are the results of an In Vitro Chewing Simulation study comparing 3M ™ ESPE™ Adult Crown and Paradigm™ MZ100 Block for CEREC®.
Based on bench testing conducted, the dinical performance of 3M TM ESPETM Adult Crown is expected to be substantially equivalent to crowns produced using Paradigm™ MZ100 Block for CEREC® and Sinfony TM Indirect Lab Composite.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
FEB | 5 LUG
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3M Company Mr. Scott Erickson Regulatory Affairs Specialist 3M ESPE Dental Products 3M Center, Building 275-2W-08 St. Paul. Minnesota 55144-1000
Re: K072733
Trade/Device Name: 3M™ ESPE™ Adult Crown Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: January 16, 2008 Received: January 18, 2008
Dear Mr. Erickson:
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 your 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.
3
Page 2 - Mr. Erickson
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 (240) 276-0115. 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 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/industry/support/index.html.
Sincerely vours.
Snyte f. Michino md.
Chiu Lin, Ph.D. 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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Image /page/4/Picture/0 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text "3M" is on the left, and the text "ESPE" is on the right.
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): ✔ ∞ア 2733
Device Name: _ 3M™ ESPE™ Adult Crown
Indications for Use:
For restoration of permanent teeth best restored with a single unit full crown (e.g. as an alternative to a complex multi-surface direct restoration)
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Kuarer
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| Page | of _______ |
|---|---|
| ------ | ------------ |
| 510(k) Number: | K072733 |
|---|---|
| ---------------- | --------- |
3M
TM ESPE
TM Adult Crown 510(k)
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