FDA · MDR · ISO 13485 • 40+ countries • Launch in 4-6 weeks • 150+brands scaling with us • No minimum orders •
Speed to market
Most partners launch within 4–6 weeks of approving their brand assets. No minimum order to test the market.
Your clinic stays yours
K Line is 100% B2B. We are the engine behind your brand, never the name on the box.
CapEx becomes OpEx
Building a certified quality system (ISO 13485, FDA, MDR) takes years. Start on ours from day one and put your capital into growing your brand.
Your price. Your margin
You set the price to your clients. Manufacturing stays a predictable cost per case, so you know your margin on every order.
Own the brand.
Keep the margin.
The value in clear aligners sits with whoever owns the brand and the clinic relationship.
A factory ties up your capital before you've sold your first case.
Manufacturing at scale
25,000 aligners produced every day. Manufactured in 3 days, delivered in 7.
Packaging with your identity
Boxes, pouches, and complete patient kits. Send your logo and get a free mockup in 48 hours.
Treatment planning, if you want it
40+ in-house orthodontists and 24h treatment plans.
Or keep your own planning workflow.
Global from day one
6 production sites on 4 continents.
Enter new markets with the same partner.
Your own branded portal
Your URL, your colors, your logo.
Your clients log into your brand, not ours.
Full compliance stack
FDA 510(k), ISO 13485, MDR, MHRA, TGA. Cross borders without rebuilding anything.
Everything behind the aligner. Handled.
SCALE
Growing an existing brand
Capacity that follows your growth, to any volume
Regional production for the US, EU, UK, and LATAM
Compliance covered in every market you enter
Your branded portal for every clinic you add
CREATE
Lauching a new aligner brand
No manufacturing experience needed
Packaging and brand assets designed with you
Onboarding, regulatory alignment, and training
No minimum order and no upfront investment
wherever you are today
Create a new brand, or scale the one you have.
Enrique Amor
CEO, Henry Aligner • Spain
Henry Aligner: from zero to 1,070+ clinics in 15 months
Launch
0
clinics, live in Spain.
month 4
300+
partner clinics
Month 15
1,070+
clinics, live in Portugal
Goal 2029
10,000+
clinics, Argentina next
All customers are super satisfied, not a single complaint.
Enrique Amor, CEO of Henry Aligner
K Line Runs
The factories, the certifications, and the production. Aligners shipped ready to the clinic.
Henry Aligner owns
The vision, the brand, the clinic relationships, and its own planning workflow.
What growing with K Line looks like.
One brand, one partner, 15 months.
Here is how Henry Aligner went from an idea to more than a thousand clinics.
how it works
From first call to first cases.
01. Strategy
Talk to our team
Your market, your volumes, your goals. We reply within 24 hours.
02. Brand
See your brand on the box
Send your logo. Free packaging mockup within 48 hours.
03. Launch
Go live in 4–6 weeks
Onboarding, regulatory alignment, training, and logistics, guided by us.
04. Scale
Grow without limits
Add clinics and markets. Our capacity grows with you.
Questions founders ask
Becoming a medical device manufacturer requires ISO 13485, FDA registration, EU MDR compliance, and a complete quality management system. That takes years and significant investment. With K Line you use a certified global infrastructure from day one and turn heavy CapEx into predictable OpEx.
After you approve your brand assets and packaging, most partners launch within 4–6 weeks. We guide you through onboarding, regulatory alignment, training, and logistics.
No. Order one case or one thousand, and grow at your own pace.
White label products are generic and sold to many companies. Private label is a true OEM partnership: aligners produced for your brand, integrated into your workflow, delivered with fully customized packaging.
You do. K Line is 100% B2B: the engine behind your brand, not the name on the box.