(201 days)
Not Found
No
The description focuses on CAD/CAM design and milling based on scanned data and a dental technician's prescription, with no mention of AI or ML algorithms for design or analysis.
Yes
The devices are indicated for restoring chewing function in partially or totally edentulous jaws, which directly addresses a physiological function.
No
Explanation: The device is a dental restorative device (a screw-retained bridge or bar) used for restoring chewing function in partially or totally edentulous jaws, not for diagnosing a condition.
No
The device description clearly states that the device is a physical dental restorative device (bars and bridges) milled from a cobalt-chromium-based blank. While software is used in the design process (CAD/CAM), the final product is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Straumann® CARES® Screw-retained Bridge and Straumann® CARES® Dolder® Bar are dental restorative devices. They are physical structures designed to replace missing teeth and restore chewing function.
- Intended Use: The intended use is to attach to dental implants in the mouth to restore chewing function. This is a mechanical and structural function, not a diagnostic test performed on a biological sample.
- Device Description: The description details the design, manufacturing process (CAD/CAM milling), and materials used for the physical dental prosthetics. It does not describe any process of analyzing biological samples for diagnostic purposes.
- Input: The input is a scan of a dental master model, which is a physical representation of the patient's mouth, not a biological sample.
Therefore, the Straumann® CARES® Screw-retained Bridge and Straumann® CARES® Dolder® Bar fall under the category of dental prosthetics or restorative devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
Product codes
76 NHA
Device Description
Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.
The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription.
Once the Straumann CARES Screw-Retained Bridge or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.
Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CAD-derived, CAMproduced and have a scanner as its data source.
The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jaws
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technician, dentist
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:
Table 2 summarizes the metallic material properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar. All properties (Color, Density, Solubility in water, Proof strength Rp0.2, Vickers hardness, Elongation after fracture, CTE (25-500°C), Solidus, Liquidus) passed acceptance criteria or were noted as not applicable.
Table 3 summaries the ceramic bonding properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar. All veneering porcelains (Initial MC (GC), IPS InLine (Ivoclar Vivadent), HeraCeram (Heraeus Kulzer), VM13 (Vita Zahnfabrik)) passed the debonding/crack-initiation strength acceptance criterion of > 25 MPa.
Table 4 summaries the biocompatibility testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar. Cytotoxicity of extract passed (
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
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DEC 1 3 2010
510(k) SUMMARY
| Submitter | |
|---|---|
| Company: | Institut Straumann AG |
| Street: | Peter Merian-Weg 12 |
| ZIP-Code, City: | CH-4002 Basel |
| Federal State: | Basel-City |
| Country: | Switzerland |
| Establishment Registration Number: | 9613348 |
| Official Correspondent: | Dr. Toni K. Joergensen, |
| Head of Corporate Regulatory Affairs | |
| Institut Straumann AG | |
| Phone: | +41 61 965 14 12 |
| Fax: | +41 61 965 11 02 |
| E-mail: | Toni.Joergensen@Straumann.com |
| Submitter: | Dr. Andreas Petermann, |
| Head of Regulatory Affairs | |
| Straumann CADCAM GmbH | |
| Phone: | +49-89-30 90 75 191 |
| Fax: | +49-89-30 90 75 119 |
| E-mail: | Andreas.Petermann@Straumann.com |
| Date: | November 23, 2010 |
| Name of Device | |
| Proprietary Name: | Straumann® CARES® Screw-Retained Bridge |
| Straumann® CARES® Dolder® Bar | |
| Classification Name | Endosseous Dental Implant Abutment |
| Common Name: | Implant Bridge |
| Regulation Number and Product Code | |
| Regulation Number: | 21 C.F.R § 872.3630 |
| Product Code: | 76 NHA |
ﻠﺴﻨﺔ
1
Predicate Devices
Procera Implant Bridge Overdenture ........................................................................................................................................... Procera Implant Bridge ....................................................................................................................................................... ETKON ES1, MODEL 019.0001, ETKON VISUAL, K093113 STRAUMANN CADCAM ABUTMENT
Device Description
Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.
Image /page/1/Picture/5 description: The image shows a round object with a complex structure on top. The object appears to be made of a rough, textured material. The structure on top consists of interconnected elements, possibly metallic, forming a network of lines and shapes. The lighting in the image is somewhat diffused, creating shadows and highlights that emphasize the texture of the object and the complexity of the structure.
Example screw retained bar to be mounted on 5 dental implants (may be fixed on 2 to 10 implants)
2
Image /page/2/Picture/1 description: The image shows a dental impression. The impression is made of a pink material and is of the upper teeth. The impression is set in a tray and is ready to be used to create a model of the teeth.
Example screw retained bridge to be mounted on 5 dental implants (may be fixed on 2 to 16 implants)
The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription.
Once the Straumann CARES Screw-Retained Bridge or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.
Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CAD-derived, CAMproduced and have a scanner as its data source.
The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and
39
3
found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.
Intended Use
The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants.
The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.
4
Technical Comparison to the Predicate Device
The Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars are equivalent in design and materials to the predicate device.
Table 1 compares the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars to the predicate devices:
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Table 1
| Characteristic | Straumann CARES®
Screw-Retained Bridge
Straumann CARES
Dolder® Bar | Procera Implant Bridge
K041236, K090069 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Indicated for use as a
screw retained bridge or
bar framework in the
treatment of partially or
totally edentulous jaws
for the purpose of
restoring chewing
function. | Same |
| Intended Use | Intended to be finished
into a bridge or
overdenture using
standard dental
laboratory techniques and
materials. | Same |
| Connection Type | Screw retained dental
restorations | Same |
| Connection Level | Dental implant | Same |
| Implant Interface Type | Straumann® RN (Regular
Neck) Ø 4.8 mm and WN
(Wide Neck) Ø 6.5 mm | Procera and Straumann
(RN (Regular Neck) Ø 4.8
mm and WN (Wide Neck)
Ø 6.5 mm) implant
interface type |
| Design Parameters | 3D scan and CAD | Same |
| Manufacturing Method | CADCAM milling from
milling blanks | Same |
| Material (bar and bridge) | chromium/cobalt dental
alloy | titanium (K041236)
titanium,
titanium/vanadium alloy,
or chromium/cobalt alloy
(K090069) |
| Finishing Method | Bridge: intended to be
finished into a bridge by
application of a veneering
porcelain layer.
Bar: intended to be
finished into overdenture
using standard dental
laboratory techniques and
materials. | Same |
Cobalt/chromium alloys are widely used in dentistry as non-precious dental alloy for cast and CADCAM fabrication of cementable crowns and
6
bridges. Such alloys are regulated by 21CFR872.3710, product code EJH and are exempt from 510(k) requirements.
Non-Clinical Testing
Table 2 summarizes the metallic material properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.
Table 2
| Property | Unit | Acceptance criteria
with and without
thermal treatment | Conclusion |
|------------------------------|-------------|--------------------------------------------------------------|------------|
| Color | na3 | Silver gray | passed |
| Density | g/cm³ | 8.3 | passed |
| Solubility in water | mg/l | insoluble | passed |
| Proof strength Rp0.2 | MPa | > 360 | passed |
| Vickers hardness | HV10 | 260 | na |
| Elongation after
fracture | % | > 2.0 | passed |
| CTE (25-500°C) | 10-6
K-1 | 14.4 | na |
| Solidus | °C | 1320 | na |
| Liquidus | °C | 1420 | na |
3 na is a notation for not applicable
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Table 3 summaries the ceramic bonding properties of the Straumann CARES Screw-Retained Bridge and Dolder Bar.
Table 3
| Veneering porcelain | Debonding/crack-
initiation strength $\tau_b$
[MPa] | Acceptance criterion | Conclusion |
|-------------------------------|-----------------------------------------------------------|----------------------|------------|
| Initial MC (GC) | > 25 MPa | | passed |
| IPS InLine (Ivoclar Vivadent) | > 25 MPa | | passed |
| HeraCeram (Heraeus Kulzer) | > 25 MPa | | passed |
| VM13 (Vita Zahnfabrik) | > 25 MPa | | passed |
Table 4 summaries the biocompatibility testing performed on the Straumann CARES Screw-Retained Bridge and Dolder Bar.
Table 4
| Test Method | Biocompatibility
Acceptance
criteria | Results |
|-----------------------------------|--------------------------------------------|---------|
| Cytotoxicity of extract |