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  "documentTitle": "Align Technology, Inc. (ALGN)",
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  "authorName": "Ben Axler",
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  "presentationDate": "2020-04-09 00:00:00",
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  "notes": "Uses a combination of a government database screenshot and a custom bar chart to visualize the acceleration of market entrants.",
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      "text": "On pace for ~18 more approvals for remainder of 2020",
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      "text": "Spruce Point believes that, with so many now obtaining FDA approvals, third-party labs are, as a whole, quickly achieving the scale and credibility necessary to pose a serious threat to established clear aligner producers.",
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      "text": "FDA 510(k) Approvals for Clear Aligner Production",
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      "text": "FDA 510(k) approvals: 33",
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      "text": "To the extent that investors are at all aware of the presence of third-party 3D printing labs... they have likely been conditioned to treat them as extremely minor players...",
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      "text": "More informed investors may have been aware of the presence of third-party 3D printing labs in the clear aligner space in prior years. Until now, however, they have been only very minor players...",
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      "text": "We are at the point where we can switch to another clear aligner vendor... There are over 100 aligner companies coming out of Asia.",
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      "text": "You can setup a clear aligner FDA approved lab in less than a year. Your capital equipment costs... less than $100K to get started.",
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      "text": "\"You can setup a clear aligner FDA approved lab in less than a year. Your capital equipment costs between buying three [high-volume] 3D printers and thermoforming machines can be less than $100K to get started. If you add in labor, your total costs in your first year will be less than $200K.\" — Senior Employee, Major Dental Equipment Supplier; \"We are at the point where we can switch to another clear aligner vendor and we would not have even entertained that two years ago... There are over 100 aligner companies coming out of Asia. Two to three years from now, I don't see how Invisalign will see the same amount of cases that they had in the past.\" — Dentist, DSO",
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      "text": "FDA Approvals For Clear Aligner Production Are Accelerating Rapidly",
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