Manufacturing for dental brands since 2014.
Tooth Shaper.
FDA Approved Facility

Fastest FDA approved aligner manufacturing in the US.

Millions of aligners made. We provide clinical-grade precision with industry-leading turnaround times for dental professionals — under your brand, on your timeline.

Manufacturing floor
Crafting Your Smile
Made in USA
10M+
Aligners fabricated
48h
Avg. turnaround
Manifesto
№ 01

We don't sell aligners. We sell capacity, precision and peace of mind — so dental brands, DSOs and ortho startups can grow without owning a factory.

Our proprietary Tooth Shaper process reduces lead times by 40% compared to traditional labs. Get cases back in days, not weeks — without sacrificing the medical-grade discipline patients deserve.

Every aligner is built from medical-grade multi-layer polymers, shaped on calibrated thermoformers and inspected at every stage. Surgically precise, comfortable and clinically proven.

Whether you're a single-doctor practice or a nation-wide DSO, our infrastructure scales with you — same SLA, same QC, same private-label dispatch. Your patients never see our name.

Capabilities

What we make.

Three product families, one factory, one quality bar. From STL to ship-ready in days — built around your brand and your case workflow.

Family 01

Clear Aligners

Multi-layer thermoformed polymers. Scalloped or straight cutline, full or partial molar coverage. Up to 40+ stages per arch, ±50µm tolerance per stage.

  • · STL / OBJ intake
  • · Cutline: scalloped or straight
  • · White-label dispatch
Family 02

Retainers

Per-arch retainers from STL or impression-kit scans. Single-arch or paired, made on the same calibrated lines as the aligners.

  • · Single-arch or paired
  • · Impression kit pipeline
  • · 48-72h turnaround
Family 03

Night Guards

Hard-soft and dual-laminate guards for bruxism and TMJ programs. Configurable molar coverage, contractor-tunable defaults.

  • · Hard-soft / dual-laminate
  • · Full or partial coverage
  • · Per-contractor defaults
Numbers

Scale without compromise.

With over 10 million aligners manufactured, our infrastructure handles everything from single-doctor practices to nation-wide DSO networks — without changing your contract, SLA or quality bar.

10M+
Aligners fabricated
48hr
Average turnaround
99.6%
First-pass QC yield
40+
Brand partners
Trust

Certified Quality Assurance.

We maintain full compliance with FDA 21 CFR Part 820 quality system regulations. Our facility undergoes rigorous monthly audits to ensure every product meets the highest medical standards in the United States.

  • Class II Medical Device Licensed
  • ISO 13485:2016 Certified
  • FDA 21 CFR Part 820
  • Made Proudly in the USA
Quality assurance inspection
Our
Fact
Speed

Unmatched Speed

Our proprietary AlignerFlow process reduces lead times by 40% compared to traditional labs. Get cases back in days, not weeks.

Precision

Clinical Precision

Using medical-grade multi-layer polymers for superior tooth movement and patient comfort. Every aligner is surgically precise.

Join our network

Ready to elevate your practice?

Set up your account in minutes and submit your first case the same day. Our implementation team will reach out within 24 hours.

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