(86 days)
The ZENEX FreeMilling & CCM Cast Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
ZENEX FreeMilling & CCM Cast Abutment consists of FreeMilling Abutment and CCM Cast Abutment.
ZENEX FreeMilling & CCM Cast Abutment is compatible with the fixtures below:
K number: K211090
Device Name: ZENEX Implant System (ZENEX MULTI&PLUS Fixture)
Dimension Ranges: Diameter 3.75 x 8.5, 10, 11.5, 13, 15; Diameter 4.25 x 7, 8.5, 10, 11.5, 13, 15; Diameter 4.6 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.05 x 7, 8.5, 10, 11.5, 13, 15; Diameter 5.4 x 7, 8.5, 10, 11.5, 13; Diameter 5.9 x 7, 8.5, 10, 11.5, 13; Diameter 6.75 x 7, 8.5, 10, 11.5, 13
Tolerance of dimension shall be within ± 1% range.
The dimensions of abutments are as following:
Device Name: FreeMilling Abutment
Dimension Ranges: Diameter 4.0/4.5/5.0/5.2/5.7/6.0/6.5/7.0
Gingival Heights (mm): 1.3/1.8/2.8/3.8
Minimum Post height (mm): 4
Angulation: 0°
Device Name: CCM Cast Abutment
Dimension Ranges: Diameter 4.0 / 4.5
Gingival Heights (mm): 0.8 / 2.8
Minimum Post height (mm): 4
Angulation: 0°
The Abutments have below featured:
Name: FreeMilling Abutment
Uses: The Abutment is connected with fixture, and it supports prosthesis which restores tooth function.
Surface: Partial TiN coated in upper
Connection: Screw retained
Name: CCM Cast Abutment
Uses: It is an abutment that is used when making a retained / customized prosthesis.
Surface: NA
Connection: Screw retained
Tolerance of dimensions for Abutments shall be within ± 1% range.
ZENEX FreeMilling & CCM Cast Abutment is provided non-sterile.
Materials:
- FreeMilling Abutment is fabricated of Ti-6Al-4V ELI according to ASTM F136-13
- CCM Cast Abutment is fabricated of Co-Cr-Mo according to ASTM F1537-11
I'm sorry, but your prompt asks for details about acceptance criteria and a study proving device performance, including a table of acceptance criteria and reported device performance, sample size, ground truth establishment, expert qualifications, adjudication methods, MRMC study information, standalone performance, and training set details.
However, the provided text is a 510(k) summary for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a primary clinical or non-clinical performance study. It mentions non-clinical test data for biocompatibility and sterilization, but it doesn't present performance metrics against specific acceptance criteria in the format you've requested for a device that relies on a performance study to prove its criteria.
The 510(k) summary establishes equivalence based on:
- Indications for Use: Same as predicate.
- Technological Characteristics: Similar design, dimensions (with minor, deemed non-critical differences), materials, and sterilization methods.
- Non-Clinical Test Data: Biocompatibility and sterilization (often leveraged from predicate devices or performed according to recognized standards).
Therefore, I cannot extract the specific information you've requested about acceptance criteria and a study proving those criteria from the given text. The document's purpose is to argue substantial equivalence, not to present a standalone performance study with detailed acceptance criteria and results.
§ 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.)