(161 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of dental polymers, with no mention of AI or ML.
No
The device, consisting of dental milling blanks, is used to fabricate temporary crowns, bridges, and bite splints, which are restorative prosthetics, not active therapeutic devices that treat a disease or condition.
No
This device is a medical polymer used for fabricating temporary crowns, bridges, and bite splints. It is a material used in the treatment phase, not a device that provides diagnostic information for a medical condition or disease.
No
The device description clearly states it is a physical dental milling blank made from medical grade polymers, intended for fabrication of physical dental structures. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for temporary crowns, bridges, and bite splints, which are physical dental prosthetics. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a dental milling blank used to fabricate physical dental structures. It's a material used in the creation of a medical device, not a diagnostic test.
- Testing: The testing performed (biocompatibility, flexural strength, water sorption, etc.) are related to the physical and chemical properties of the material for its intended use as a dental prosthetic, not for diagnostic purposes.
The device is a dental material used in the fabrication of dental prosthetics, which are medical devices, but it is not an IVD.
N/A
Intended Use / Indications for Use
DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.
Product codes (comma separated list FDA assigned to the subject device)
EBG, MQC
Device Description
DD medical polymers, made from medical grade, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints (clear variant) on dental CAD/CAM systems.
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)
Non-clinical testing according to the following standards was performed in order to validate the product against the company's specified design requirements:
- EN ISO 10993-1 (biological compatibility) and EN ISO 10993-5 (cytotoxicity): Finished DD medical polymer products in all variants were tested by an accredited testing laboratory (GLP-certified) with respect to biocompatibility. The laboratory certified that "the insolubility is in compliance with the requirements of the standard. There is no evidence that effects hazardous to the patient will arise by release of leachable ingredients/contaminants".
- DIN EN ISO 20795-1:2013: Dentistry - Base polymers - Part 1: Denture base polymers
- ISO 10477:2004: Dentistry Polymer-based Crown and Bridge Materials
Key Results:
- Flexural strength [MPa]: Submitted device ≥ 75, Predicate device 90. Passed.
- Flexural modulus [MPa]: Submitted device 2800 (± 200), Predicate device not specified. Passed.
- Residual MMA monomer [%]: Submitted device 0.4, Predicate device 1.4. Passed.
- Water sorption [µg/mm3]: Submitted device ≤ 23, Predicate device 23. Passed.
- Solubility [µg/mm3]: Submitted device 0.2, Predicate device 0.0. Passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural strength, Flexural modulus, Residual MMA monomer, Water sorption, Solubility.
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
§ 872.3770 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13,2016
Dental Direkt Gmbh % Ms. Vera Buescher Quality & Regulatory Manager Dental DireK153490/S001kt Gmbh (former Dental Direkt Of Amerika Ug) Industriezentrum 106-108 Spenge, 32139 DE
Re: K153490
Trade/Device Name: Dd Medical Polymers Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: April 11, 2016 Received: April 14, 2016
Dear Ms. Buescher:
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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K153490
DD medical polymers: Device Name: - DD tempMED - DD Bio Splint P
Indications for Use:
DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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Image /page/3/Picture/1 description: The image contains the logo for Dental Direkt. The logo consists of a square grid of smaller squares, with one square colored gold. To the right of the grid is the text "Dental Direkt" in a sans-serif font. The text is a light gray color.
510(k) Number: K153490
510(k) Summary
| Submitter of 510(k) | Dental Direkt GmbH
Industriezentrum 106-108
32139 Spenge / Germany | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons | Mr. Uwe Greitens, Authorized Representative
Ms. Vera Büscher, Quality & Regulatory Manager
Phone:+49 5225 86319-0
Fax: +49 5225 86319-99 | |
| Establishment
Registration Number | 3008347275 | |
| Date Prepared | 2016/05/12 | |
| Trade Name of Device | DD medical polymers:
- DD tempMED
- DD Bio Splint P | |
| Common Name | Crown and Bridge, Temporary, Resin | |
| Classification Name | Temporary crown and bridge resin | |
| Regulation Number | 21 CFR 872.3770 | |
| Classification Product Code | EBG, MQC | |
| Panel | Dental | |
| Classification | Class II | |
| Predicate Device | K150432:
Union Dental S.A.
Idodentine (Dental Polymer Blank) | |
| Indications for Use | DD medical polymers are indicated for temporary
(≤ 12 months) crowns, bridges and bite splints.
Applications include both anterior and posterior
structures. | |
| Device Description | DD medical polymers, made from medical grade,
are industrially polymerized, pre-colored or clear
dental milling blanks designed for milled fabrication
of temporary anterior and posterior crowns and
bridges (tooth-colored variants) or bite splints (clear
variant) on dental CAD/CAM systems. | |
| Technological
characteristics | The technologic characteristics are highly similar as
demonstrated in performance testing and in
chemical composition; both devices are composed
primarily of polymethylmethacrylate, while the
amount and percentage of color oxides in the
submission device varies from the predicate. | |
| Comparison of
Required Technology
Characteristics | The following table shows a summary of the
technological characteristics of DD medical
polymers compared to the predicate device. | |
| Comparison of Required Technology Characteristics | | |
| Feature | Submission device | Predicate device |
| Trade name | DD medical polymers | Idodentine Disc |
| 510(k) | K153490 | K150432 |
| Product code | EBG, MQC | EBG |
| Regulatory class | Class II | Class II |
| Manufacturer | Dental Direkt GmbH | Union Dental S.A. |
| Intended use | DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures. | Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications - Temporary anterior and posterior crowns
- Temporary anterior and posterior bridges with up to two adjacent pontics
Maximum recommended usage period: 12 months - Removable structures for dentures (denture bases)
- Removable structures for therapeutic restorations (bite splints or occlusal splints) |
| Max. application time | 12 months | 12 months |
| Technology | Blank for dental CAD/CAM machining | Blank for dental CAD/CAM machining |
| Shape | Disc | Disc or block |
| Shade | VITA-shades, clear | VITA-shades, clear, pink |
| Comparison of Required Technology Characteristics | | |
| Raw material | PMMA | PMMA |
| Chemical composition [Units] | | |
| Material base | > 99.0 [wt%]
(Polymethyl methacrylate) | Polymethyl methacrylate |
| Coloring oxides | ≤ 1.0 [wt%] | Not specified |
| Physical characteristics [Units] | | |
| Performance testing | Tested according to DIN EN ISO 20795-1 and ISO 10477 | Tested according to DIN EN ISO 20795-1 and ISO 10477 |
| Biocompatibility | EN ISO 10933-1, -5 | EN ISO 10933-1, -5. |
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| Discussion of
Tests Performed | Clinical Tests
Dental Direkt GmbH did not conduct, nor rely upon, clinical |
|----------------------------------|-------------------------------------------------------------------------------|
| | tests to determine substantial equivalence. |
Non Clinical Tests
Non-clinical testing according to the following standards was performed in order to validate the product against the company's specified design requirements:
-
EN ISO 10993-1 (biological compatibility) and EN ● ISO 10993-5 (cytotoxicity):
Finished DD medical polymer products in all variants were tested by an accredited testing laboratory (GLP-certified) with respect to biocompatibility. The laboratory certified that "the insolubility is in compliance with the requirements of the standard. There is no evidence that effects hazardous to the patient will arise by release of leachable ingredients/contaminants". -
. DIN EN ISO 20795-1:2013: Dentistry - Base polymers - Part 1: Denture base polymers
-
ISO 10477:2004: Dentistry Polymer-based Crown . and Bridge Materials
| Requirements acc. to DIN EN ISO 20795-1 / ISO 10477: | |||||
|---|---|---|---|---|---|
| Requirement | Required | ||||
| Value | |||||
| (ISO 20795-1) | Required | ||||
| Value | |||||
| (ISO 10477) | Value | ||||
| Subm. | |||||
| Device | Value | ||||
| Predicate | |||||
| Device | Passed / | ||||
| Failed | |||||
| Flexural | |||||
| strength [MPa] | ≥ 65 | ≥ 50 | ≥ 75 | 90 | Passed |
| Flexural | |||||
| modulus [MPa] | ≥ 2000 | 2800 | |||
| (± 200) | not | ||||
| specified | Passed | ||||
| Residual MMA | |||||
| monomer [%] | ≤ 2.2 | 0.4 | 1.4 | Passed | |
| Water sorption | |||||
| [µg/mm3] | ≤ 32 | ≤ 40 | ≤ 23 | 23 | Passed |
| Solubility | |||||
| [µg/mm3] | ≤ 1.6 | ≤ 7.5 | 0.2 | 0.0 | Passed |
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Substantial Equivalence Conclusion
The small difference in the indication of the predicate device is due to a bigger range of shades available. The missing pink variant by Dental Direkt is the only reason why the application field of denture bases is not contained in the indication of DD medical polymers. The restriction regarding the maximum amount of pontics for bridge constructions is listed as contraindication in the IFU of DD medical polymers. In summary neither the fundamental intended use nor the safety and effectiveness of the product is influenced by the deviation of the indication of submission device and predicate device. Based on comparison of technology, including composition and performance testing, biocompatibility testing, and highly similar indications for use, DD medical polymers are substantially equivalent to Idodentine (K150432).