OEM manufacturing of orthodontic aligners, whitening trays and treatment plans for dental companies

Ensmile Aligners (Germany)

Hamburg (DE) · Maia (PT) · Lahore (PK)New on Amplifa

2017Start of production according to own statement

2021Founding of the LinkedIn entity in Hamburg

5 business daysStated delivery time

3 locationsHamburg, Maia, Lahore

About Ensmile Aligners (Germany)

Ensmile Aligners (Germany), headquartered in Hamburg, is a B2B provider in the medical devices sector specialising in the manufacture of invisible dental aligners. According to its own statements, the company has been producing aligners, whitening trays (bleaching trays) and treatment plans since 2017. Its offering targets orthodontic professionals and companies that wish to sell aligners under their own brand (OEM/private label). The value chain includes AI-supported treatment planning with 3D simulation, the manufacture of aligners from dental materials, as well as personalised packaging designs and aligner accessories. In addition, intraoral scanners and dental materials are offered; the stated delivery time is five business days. Locations exist in Hamburg, Maia (Portugal) and Lahore (Pakistan); according to the company, it delivers worldwide.

Site: Hamburg
Processes: Invisible Aligner Manufacturing (OEM/private-label aligner manufacturing), Treatment Planning (AI-supported treatment planning with 3D simulation), Packaging and Aligner Accessories (personalised packaging and design), Whitening Trays Production (bleaching trays), Intraoral Scanners (service/sales), Dental Materials (offering of dental materials), OEM/private-label aligner manufacturing, Treatment planning (AI-supported, 3D simulation)
Materials: Aligner/dental materials (unspecified, 'wide range of the finest materials'), Dental/aligner plastics
Certificates: ISO 12485, MDR compliant, FDA 510(k) cleared (website: "FDA 501k"), FDA 510(k)
Founded: 2021 (Link
Industries: Orthodontics, Dentistry, Medical device manufacturing (dental aligners)

01
Treatment planning (AI-supported, 3D simulation)
02
Aligner manufacturing
03
Whitening trays production
04
Packaging and aligner accessories

Materials and Processes

PET

Dental/aligner plastics

Ensmile states that it offers a wide range of high-quality materials for aligners; specific materials are not named.

Locations

Hamburg

Headquarters

Maia

Location with Warehouse C1 & C2

Lahore

Asia location

Products

**Invisible dental aligner**Aligner manufacturing · Orthodontics

**Intraoral scanner**Service/sales · Dentistry

Inside the production

Video material of the manufacturing process

Industries

OrthodonticsDentistryMedical device manufacturing (dental aligners)

Processes & technical limits

Processes	Tolerance	Max. part	Weight	Lot size	Materials
Invisible Aligner Manufacturing (OEM/private-label aligner manufacturing)Plastics	–	–	–	–	–
Treatment Planning (AI-supported treatment planning with 3D simulation)Engineering	–	–	–	–	–
Packaging and Aligner Accessories (personalised packaging and design)Assembly	–	–	–	–	–
Whitening Trays Production (bleaching trays)Plastics	–	–	–	–	–
Intraoral Scanners (service/sales)Testing	–	–	–	–	–
Dental Materials (offering of dental materials)Other	–	–	–	–	–

Additional services

OEM/private-label aligner manufacturingTreatment planning (AI-supported, 3D simulation)Packaging design and aligner accessoriesIntraoral scannersDental materialsWhitening traysDelivery time 5 business days

Quality

Ensmile lists ISO 12485 as a certification, MDR conformity and FDA 510(k) clearance on its website; details on internal quality assurance are not provided.

Evidence	Hamburg
ISO 12485
MDR compliant
FDA 510(k)

History

2017
According to its own statement, start of production of aligners, whitening trays and treatment plans
2021
Founding of the LinkedIn entity Ensmile Aligners (Germany) in Hamburg