DD medical polymers

K153490 · Dental Direkt GmbH · EBG · May 13, 2016 · Dental

Device Facts

• Record ID: K153490
• Device Name: DD medical polymers
• Applicant: Dental Direkt GmbH
• Product Code: EBG · Dental
• Decision Date: May 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.

Device Story

DD medical polymers are industrially polymerized, pre-colored or clear PMMA dental milling blanks; used by dental technicians or clinicians with dental CAD/CAM systems to fabricate temporary anterior/posterior crowns, bridges, and bite splints. The device is a raw material blank that undergoes subtractive milling to create patient-specific dental prosthetics. The final output is a temporary dental restoration that provides functional and aesthetic support for up to 12 months. Benefits include patient comfort and temporary tooth function during the interim period before permanent restoration.

Clinical Evidence

No clinical data. Bench testing performed according to DIN EN ISO 20795-1:2013 and ISO 10477:2004. Results: Flexural strength ≥ 75 MPa (req ≥ 65), Flexural modulus 2800 MPa (req ≥ 2000), Residual MMA monomer 0.4% (req ≤ 2.2), Water sorption ≤ 23 µg/mm3 (req ≤ 32), Solubility 0.2 µg/mm3 (req ≤ 1.6). Biocompatibility validated per ISO 10993-1 and -5.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) > 99.0 wt%, coloring oxides ≤ 1.0 wt%. Form factor: Milling discs. Energy source: None (mechanical milling). Sterilization: Not specified. Standards: DIN EN ISO 20795-1, ISO 10477, ISO 10993-1, ISO 10993-5.

Indications for Use

Indicated for temporary (≤ 12 months) crowns, bridges, and bite splints in anterior and posterior dental structures.

Regulatory Classification

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.

Predicate Devices

• Idodentine (Dental Polymer Blank) (K150432)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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<br>Industriezentrum 106-108<br>32139 Spenge / Germany | |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons | Mr. Uwe Greitens, Authorized Representative<br>Ms. Vera Büscher, Quality & Regulatory Manager<br>Phone:[phone]<br>Fax: [phone] | |
| Establishment<br>Registration Number | 3008347275 | |
| Date Prepared | 2016/05/12 | |
| Trade Name of Device | DD medical polymers:<br>- DD tempMED<br>- 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:<br>Union Dental S.A.<br>Idodentine (Dental Polymer Blank) | |
| Indications for Use | DD medical polymers are indicated for temporary<br>(≤ 12 months) crowns, bridges and bite splints.<br>Applications include both anterior and posterior<br>structures. | |
| Device Description | DD medical polymers, made from medical grade,<br>are industrially polymerized, pre-colored or clear<br>dental milling blanks designed for milled fabrication<br>of temporary anterior and posterior crowns and<br>bridges (tooth-colored variants) or bite splints (clear<br>variant) on dental CAD/CAM systems. | |
| Technological<br>characteristics | The technologic characteristics are highly similar as<br>demonstrated in performance testing and in<br>chemical composition; both devices are composed<br>primarily of polymethylmethacrylate, while the<br>amount and percentage of color oxides in the<br>submission device varies from the predicate. | |
| Comparison of<br>Required Technology<br>Characteristics | The following table shows a summary of the<br>technological characteristics of DD medical<br>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<br>- Temporary anterior and posterior crowns<br>- Temporary anterior and posterior bridges with up to two adjacent pontics<br>Maximum recommended usage period: 12 months<br>- Removable structures for dentures (denture bases)<br>- 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%]<br>(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<br>Tests Performed | Clinical Tests<br>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<br>Value<br>(ISO 20795-1) | Required<br>Value<br>(ISO 10477) | Value<br>Subm.<br>Device | Value<br>Predicate<br>Device | Passed /<br>Failed |
| Flexural<br>strength [MPa] | ≥ 65 | ≥ 50 | ≥ 75 | 90 | Passed |
| Flexural<br>modulus [MPa] | ≥ 2000 | | 2800<br>(± 200) | not<br>specified | Passed |
| Residual MMA<br>monomer [%] | ≤ 2.2 | | 0.4 | 1.4 | Passed |
| Water sorption<br>[µg/mm3] | ≤ 32 | ≤ 40 | ≤ 23 | 23 | Passed |
| Solubility<br>[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).