(358 days)
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No
The document describes a dental material (PEEK polymer) used for fabricating restorations via CAD/CAM, and its physical properties. There is no mention of AI or ML technology.
No
This device is a material (polymer) used for fabricating dental restorations, not a therapeutic device itself.
No
Explanation: The device is described as a material (polymer/PEEK) used for fabricating dental restorations like crowns and bridges, not for diagnosing conditions.
No
The device description clearly states that BioHPP and breCAM.BioHPP are physical materials (polymers) used for fabricating dental restorations, 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 the BioHPP polymer and breCAM.BioHPP are used for the fabrication of dental restorations (crowns, bridges, frameworks, etc.). This is a direct application within the body or for creating devices that will be placed in the body.
- Device Description: The description confirms it's a material (polymer) used for creating these dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The performance studies focus on the physical properties of the material itself, not its ability to detect or measure biological markers.
IVD devices are specifically designed to perform tests in vitro (outside the living body) on biological samples to gain diagnostic information. This device is a material used to create a medical device (dental restoration) that is placed in vivo (within the living body).
N/A
Intended Use / Indications for Use
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.
- Fully anatomical crowns and bridges (max. 2 pontics)
- Crown copings and bridge substructures for composite veneers (max. 2 pontics)
- Telescopic primary and secondary crowns and frameworks
- Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide
breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.
Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection)
Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section))
Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use "BioHPP elegance prefab for SKY" to fabricate an individual abutment.
Product codes
EBF
Device Description
BioHPP is a tooth-colored thermoplastic high-performance polymer based on polyether ether ketone (PEEK), which was developed especially for the fabrication of dental restorations. Bio HPP is available in two different variations - as a granular material and prefabricated cylinders with diameters of 15 mm and 25 mm (so-called pellets). The two different pellets have a weight of 4 g (diameter: 15 mm) and 15 g (diameter: 25 mm). The small pellets with a diameter of 15 mm can be used in the smaller mold with a diameter of the press plunger of 16 mm. The large pellets with a diameter of 25 mm are intended exclusively for processing in the large mold with a press plunger diameter of 26 mm. In addition to high biocompatibility, BioHPP material features high mechanical, thermal and chemical resistance. BioHPP is melted in a standard preheating furnace at 400° C and pressed into an investment ring in the for 2 press vacuum press device, which is required for this application.
breCAM.BioHPP is based on filled polyether ether ketone (PEEK) and used for the fabrication of permanent crowns and bridges using CAD/CAM techniques. Three sizes are available.
54002029 breCAM.BioHPP Ø 98,5 x 12 mm
54002030 breCAM.BioHPP Ø 98,5 x 16 mm
54002031 breCAM.BioHPP Ø 98,5 x 20 mm
54002032 breCAM.BioHPP Ø 98,5 x 24 mm
54002089 breCAM.BioHPP Ø 95 x 12 mm ZZ
54002091 breCAM.BioHPP Ø 95 x 20 mm ZZ
54002092 breCAM.BioHPP Ø 95 x 25 mm ZZ
54002111 breCAM.BioHPP Ø 84,5 x 20 mm AG
breCAM.BioHPP dentin-shade 2
54002069 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 12 mm
54002070 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 16 mm
54002071 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 20 mm
54002072 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 24 mm
54002099 breCAM.BioHPP dentin-shade 2 Ø 95 x 12 mm ZZ
54002101 breCAM.BioHPP dentin-shade 2 Ø 95 x 20 mm ZZ
54002102 breCAM.BioHPP dentin-shade 2 Ø 95 x 25 mm ZZ
54002121 breCAM.BioHPP dentin-shade 2 Ø 84,5 x 20 mm AG
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
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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)
To evaluate the physical properties of BioHPP and breCAM.BioHPP tests according DIN EN ISO 10477 (ISO 10477:2004) have been performed.
Biocompatibility: All requirements of biocompatibility are met through the composition of the used materials which demonstrate the appropriate levels of biocompatibility for its intended use. The used materials are also used in many other medical devices and have an established history of use and biocompatibility. Performed testing provides evidence on acceptable levels of biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for material properties were provided in a table comparing the new device with predicate devices:
- Water absorption: BioHPP: 6.5 µg/mm³
- Water solubility: BioHPP: 0.1 µg/mm³
- Bond strength to veneering resins (≥ 15 MPa): BioHPP: 25.2 MPa
- Bond strength to veneering resins after thermocycling (≥ 15 MPa): BioHPP: 21.4 MPa
- Surface roughness after polishing (SA) [µm]: BioHPP: 0.057 µm
- Density [g/cm³]: BioHPP: 1.4425 g/cm³
- Modulus of elasticity (3.800 – 5000 MPa): BioHPP: 4083 ÷ 4630 MPa, breCAM.BioHPP: 4550÷4620 MPa
- Modulus of elasticity after thermocycling (3800 – 5000 MPa): BioHPP: 3970 ÷ 4640 MPa, breCAM.BioHPP: 4610÷4780 MPa
- Flexural strength (>150 MPa): BioHPP: 163 ÷ 179 MPa, breCAM.BioHPP: 174 ÷ 182 MPa
- Flexural strength after thermocycling (>150 MPa): BioHPP: 157 ÷ 171 MPa, breCAM.BioHPP: 173 ÷ 174 MPa
- Elongation at fracture (>6.5%, no fracture): BioHPP: >7% ÷ >9% no fracture, breCAM.BioHPP: >8% ÷ >9% no fracture
- Elongation at fracture after thermocycling (>6.5%, no fracture): BioHPP: >7% ÷ >9% no fracture, breCAM.BioHPP: >7% ÷ >9% no fracture
- Fracture load 3-unit bridge (>800 N): BioHPP: 1307 N, breCAM.BioHPP: 1387 N
- Elongation at fracture from fracture load (>7%, no fracture): BioHPP: No fracture, breCAM.BioHPP: No fracture
- Fracture load after mechanical and thermal load cycles (>800 N): BioHPP: 1500 N
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 stylized symbol. The symbol consists of three overlapping human profiles facing to the right, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 21, 2016
Bredent Gmbh & Co.KG Stefanie Bochtler Head Of Approvals And Regulatory Affairs Weissenhorner Strasse 2 Senden, DE 89250 Bayern
Re: K152113
Trade/Device Name: BioHPP - breCAM.BioHPP Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 2, 2016 Received: June 8, 2016
Dear Stefanie Bochtler:
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 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.
1
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,
Michae Døyan -S
for 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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Image /page/2/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are all lowercase and connected, giving the word a flowing appearance. The color of the text is black, and the background is white.
Indications for Use Statement
510(k) Number: K152113
Device Name: BioHPP
Indications for Use:
BioHPP polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.
- · Fully anatomical crowns and bridges (max. 2 pontics)
- · Crown copings and bridge substructures for composite veneers (max. 2 pontics)
- · Telescopic primary and secondary crowns and frameworks
• Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 SFR 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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Indications for Use Statement
510(k) Number: K____________
Device Name: breCAM.BioHPP
Indications for Use:
breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.
Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection)
Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section))
Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use "BioHPP elegance prefab for SKY" to fabricate an individual abutment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _______________________________________________________________________________________________________________________________________________________ (21 SFR 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/4/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are all lowercase and evenly spaced. The font is thin and modern, giving the word a clean and minimalist appearance. The color of the text is black.
K
VOLUME 006
510(k) Summary
DATE OF APPLICATION: 2015-07-17
APPLICANT: bredent GmbH & Co.KG Weissenhorner Strasse 2 D-89250 Senden Germany Tel.: (+49) 0 7309 / 872 0 Fax: (+49) 0 7309 / 872 444 E-Mail: info@bredent.com Internet: www.bredent.com CONTACT PERSON:Stefanie Bochtler Tel.: (+49) 0 7309 / 872 531 E-Mail: stefanie.bochtler@bredent.com
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1. Device Name
BioHPP - breCAM.BioHPP Trade Names: Common Name: Dental material Classification Name: material, tooth shade, resin.
2. Classification Product Code / Subsequent Code
Bredent BioHPP and breCAM.BioHPP can be classified according to following FDA Device Name and Product Code:
| | Device | Regulation
Medical Spe-
ciality /
Review Panel | Product
Code | Device
Class | Regulation
Description | Regulation
Number |
|-----------|---------------------------------|---------------------------------------------------------|-----------------|-----------------|-------------------------------------|----------------------|
| Predicate | Material, Tooth
Shade, Resin | Dental | EBF | 2 | Tooth shade
resin mate-
rial. | 872.3690 |
3. Predicate Device
Bredent BioHPP and breCAM.BioHPP are substantially equivalent to the following predicate devices, already cleared by the FDA:
| Predicate Device | 510(k) Number | 510(k) Holder |
|---|---|---|
| TRINIA | K133608 | BICON, LLC |
| 501 Arborway | ||
| Boston, MA 02130 | ||
| Juvora PEEK | K132725 | JUVORA Technology |
| Centre Hillhouse | ||
| International | ||
| Thornton-cleveleys, Lancashire, GB fy5 4qd |
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Image /page/6/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are evenly spaced and have a consistent line weight, giving the word a clean and modern appearance. The font is a light color, possibly white or a very light gray, against a darker background, which makes the word stand out. The overall design is minimalist and focuses on the clarity and readability of the brand name.
4. Description of the Device
4.1. BioHPP
BioHPP is a tooth-colored thermoplastic high-performance polymer based on polyether ether ketone (PEEK), which was developed especially for the fabrication of dental restorations. Bio HPP is available in two different variations - as a granular material and prefabricated cylinders with diameters of 15 mm and 25 mm (so-called pellets). The two different pellets have a weight of 4 g (diameter: 15 mm) and 15 g (diameter: 25 mm). The small pellets with a diameter of 15 mm can be used in the smaller mold with a diameter of the press plunger of 16 mm. The large pellets with a diameter of 25 mm are intended exclusively for processing in the large mold with a press plunger diameter of 26 mm. In addition to high biocompatibility, BioHPP material features high mechanical, thermal and chemical resistance. BioHPP is melted in a standard preheating furnace at 400° C and pressed into an investment ring in the for 2 press vacuum press device, which is required for this application.
Overview of capacities:
| BioHPP Type of material | Base former, size 3, with a
diameter of 16 mm | Base former, size 9, with a
diameter of 20 mm | Base former, size 9, with
a diameter of 26 mm and
metal ring |
|--------------------------|--------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------|
| Granular material | max. 4,6 g | max. 8,7 g | max. 15 g |
| Pellet 15 mm (4 g each) | 1 pellet | 2 pellets | 3 pellets |
| Pellet 25 mm (15 g each) | not possible | not possible | 1 pellet |
4.2. breCAM.BioHPP
breCAM.BioHPP is based on filled polyether ether ketone (PEEK) and used for the fabrication of permanent crowns and bridges using CAD/CAM techniques. Three sizes are available.
54002029 breCAM.BioHPP Ø 98,5 x 12 mm 54002030 breCAM.BioHPP Ø 98,5 x 16 mm 54002031 breCAM.BioHPP Ø 98,5 x 20 mm 54002032 breCAM.BioHPP Ø 98,5 x 24 mm
54002089 breCAM.BioHPP Ø 95 x 12 mm ZZ 54002091 breCAM.BioHPP Ø 95 x 20 mm ZZ 54002092 breCAM.BioHPP Ø 95 x 25 mm ZZ 54002111 breCAM.BioHPP Ø 84,5 x 20 mm AG
breCAM.BioHPP dentin-shade 2
54002069 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 12 mm 54002070 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 16 mm 54002071 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 20 mm 54002072 breCAM.BioHPP dentin-shade 2 Ø 98,5 x 24 mm
54002099 breCAM.BioHPP dentin-shade 2 Ø 95 x 12 mm ZZ 54002101 breCAM.BioHPP dentin-shade 2 Ø 95 x 20 mm ZZ 54002102 breCAM.BioHPP dentin-shade 2 Ø 95 x 25 mm ZZ 54002121 breCAM.BioHPP dentin-shade 2 Ø 84,5 x 20 mm AG
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Image /page/7/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are all lowercase and connected, giving the word a flowing appearance. The color of the text is black, and the background is white, creating a high contrast that makes the word easily readable.
5. Indications for Use
5.1. BioHPP
BioHPP high-performance polymer is used for the fabrication of definitive crown and bridge frameworks with no more than 2 pontics and for definitive removable restorations. BioHPP can also be used for fully anatomical pressed bridge structures - with or without buccal composite veneering.
- · Fully anatomical crowns and bridges (max. 2 pontics)
- · Crown copings and bridge substructures for composite veneers (max. 2 pontics)
- · Telescopic primary and secondary crowns and frameworks
• Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide
5.2. breCAM.BioHPP
breCAM.BioHPP is used for the fabrication of permanent restorations using CAD/CAM techniques.
Fully anatomical crowns and bridges (max. 2 pontics and min. 13 mm² connector crosssection)
Crown copings and bridge substructures for composite veneering (max. 2 pontics and min. 13 mm² connector cross-section))
Telescopic primary and secondary crowns and frameworks Secondary bar structures on primary bars made of titanium alloy, CoCr alloys, gold alloy, zirconium dioxide. Reference is made to the instructions for use "BioHPP elegance prefab for SKY" to fabricate an individual abutment.
| NEW DEVICE | NEW DEVICE | PREDICATE DEVICE 1 | PREDICATE DEVICE 2 | |
|---|---|---|---|---|
| 510(k) | ||||
| Submitter/ | ||||
| Holder | Bredent | Bicon LLC | Juvora | |
| Trade | ||||
| Name | BioHPP | breCAM.BioHPP | TRINIA | Juvora PEEK |
| 510(k) | ||||
| Number | - | K133608 | K132725 | |
| Material | PEEK | Glass fiber | ||
| Modified epoxy resin | PEEK-OPTIMA LT1 | |||
| Shape | Granulate - Pellets | Disc | Disc | Disc |
| Melting | ||||
| temperature/ | ||||
| range | ||||
| 150 MPa | 163 ÷ 179 MPa | 174 ÷ 182 MPa | Flexural | |
| strength | 393MPa | |||
| NEW DEVICE | NEW DEVICE | PREDICATE DEVICE | ||
| 1 | PREDICATE DEVICE | |||
| 2 | ||||
| 510(k) | ||||
| Submit- | ||||
| ter/ | ||||
| Holder | Juvora | |||
| Trade | ||||
| Name | BioHPP | breCAM.BioHPP | TRINIA | Juvora PEEK |
| Flexural | ||||
| strength | ||||
| after | ||||
| thermocy- | ||||
| cling |
150 MPa | $157 ÷ 171$ MPa | $173 ÷ 174$ MPa | - | - |
| Elongation
at fracture
6.5%, no
fracture | >7% ÷ >9% no fracture | >8% ÷ >9% no frac-
ture | Flexural
strain at
max stress | 2.7 % |
| Elongation
at fracture
after
thermocy-
cling
6.5%, no
fracture | >7% ÷ >9% no fracture | >7% ÷ >9% no frac-
ture | - | - |
| Fracture
load 3-unit
bridge
800 N | 1307 N | 1387 N | - | - |
| Elongation
at fracture
from
fracture
load
7%, no
fracture | No fracture | No fracture | - | - |
| Fracture
load after
mechani-
cal and
thermal
load
cycles
800 N | 1500 N | - | - | - |
6. Technological Characteristics
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Image /page/8/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are evenly spaced and have a consistent line weight. The overall impression is clean and modern. The word is presented in a horizontal format.
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Image /page/9/Picture/1 description: The image shows the word "bredent" in a simple, sans-serif font. The letters are evenly spaced and have a consistent line weight, giving the word a clean and modern appearance. The word is presented in all lowercase letters. The overall design is minimalist and focuses on the clarity and readability of the text.
7. Testing
To evaluate the physical properties of BioHPP and breCAM.BioHPP tests according DIN EN ISO 10477 (ISO 10477:2004) have been performed.
8. Biocompatibility
All requirements of biocompatibility are met through the composition of the used materials which demonstrate the appropriate levels of biocompatibility for its intended use. The used materials are also used in many other medical devices and have an established history of use and biocompatibility. Performed testing provides evidence on acceptable levels of biocompatibility.
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Compared with competitor devices, Bredent BioHPP and breCAM.BioHPP are made out of substantially equivalent or identical materials.
9. Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, BioHPP and breCAM.BioHPP are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design and performance specifications.