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510(k) Data Aggregation
(220 days)
UTA AND UHA
The UTA is intended for use to fabricate and support provisional restorations that aid in creating proper emergence profiles and support gingival architecture throughout the healing phase. It is for use in single tooth restorations in the maxilla or mandible, with non occlussal loading. The UTA can be used for up to one hundred eighty days (180) intra orally.
The UTA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.
UHA are placed on top of implants to protect the inner components of the implants throughout the healing phase. UHA creates support for gingival architecture and can be used with cement-retained temporary prostheses. It should be placed in non occlusal loading. It can be used for up to 180 days.
The UHA is compatible with AstraTech 3.5/4.0 & 4.5/5.0, Biohorizons 3.2/4.5/6, Biomet 3.4, 4.1 & 5, Nobel Biocare Branemark, Nobel Biocare Active Internal RP(4.1/5)&NP(3.5), Nobel Biocare Select NP(3.5)& RP/WP(4.3/5), Nobel Biocare Replace 4.3, Straumann Bone Level NC &RC (4), and Zimmer 3.75, 4.5 &6.
UHA is a healing abutment which is a PEEK screw-retained post. UTA is a screwretained temporary abutment which is a PEEK post with a predefined apex so a preformed tooth can be attached. Screws are available for Astra Tech 3.5/4.0 &4.5/5.0, Biohorizon 3.2/4.5/6.0, Biomet 3.4/4.0/5.0, Nobel Biocare Branemark, Nobel Biocare Active Internal 4.1/5.0(RP/WP) & 3.5(NP), Nobel Biocare Select 4.3/5.0(RP/WP) & 3.5(NP), Nobel Biocare Replace 4.3, Straumann Bone Level 4.0 NC &RC, Zimmer 3.75/4.5/6.0.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria | Reported Device Performance |
---|---|
Static Strength | Similar strength to predicate temporary abutments (Astra Tech, Biomet, Zimmer). |
**Fatigue Life (1 Million Cycles, adjusted for |
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