Development and manufacture of dental implant systems, surgical instruments, prosthetics and biomaterials made of titanium
Biotec Implant GmbH
Kassel (DE) · Mooresville, NC (US) · Bucharest (RO) · Delhi (IN) · La Mesa, CA (US) · Phnom Penh (KH) · Niscemi (IT) · Istanbul (TR) · Aleppo (SY)New on Amplifa
About Biotec implant
Biotec implant GmbH is a German dental implant company founded in 2005 and headquartered in Kassel, run by dentists for dentists. The company develops and manufactures a complete range of dental solutions: implant systems (Conical Connection B1, Internal Hex, Internal Hex 2.0 S1, One Piece ARP), surgical kits and drills, prosthetics, CAD/CAM digital solutions and biomaterials. All implants are made from the titanium alloy Ti 6Al 4V ELI (Grade 23), coated with a thin layer of pure titanium dioxide (TiO2) and surface-treated by RBM blasting (resorbable blast media) with calcium phosphate to enhance osseointegration. Production takes place in the company's own manufacturing facilities in Germany in accordance with ISO 13485 and ISO 9001; packaging of the sterile-packed products with a double sterile barrier and batch documentation is performed in a Class 7 cleanroom per ISO 14644. In addition to its headquarters in Kassel, Biotec maintains sales locations or distributors among others in the USA, Romania, India, Italy, Turkey, Cambodia and Syria. By 2019, one million Biotec implant products had been sold.
- Site
- Kassel
- Processes
- Manufacture of dental implant systems (Conical Connection B1, Internal Hex, Internal Hex 2.0, RBM surface treatment (resorbable blast media, calcium phosphate) and titanium acid coating, CAD/CAM restoration (digital solutions), Packaging in an ISO Class 7 cleanroom (double sterile barrier system, 3-year sterility), Testing: SEM examinations as well as static and cyclic load tests (CIM, SPR, SPTT), Manufacture of surgical instruments, drills, surgical kits, prosthetics and biomaterials, CAD/CAM digital solutions, Prosthetics
- Materials
- Titanium alloy Ti 6Al 4V ELI (Grade 23), Titanium dioxide (TiO2) coating, Calcium phosphate (RBM blast media), Titanium dioxide coating, Calcium phosphate (RBM blast treatment)
- Certificates
- ISO 13485:2003, ISO 9001:2008, CE 1023 (MDD 93/42/EEC), Clean Room Class 7 per ISO 14644, ISO 9001, ISO 13485, Class 7 cleanroom (ISO 14644), SEM testing and load tests
- Founded
- 2005
- Industries
- Dental medicine, Dental implants, Medical technology
- 01
Development and CAD/CAM design
- 02
Manufacture of implants from Ti 6Al 4V ELI (Grade 23)
- 03
RBM surface treatment with calcium phosphate and TiO2 coating
- 04
Testing (SEM examination, static and cyclic load tests)
- 05
Packaging in the Class 7 cleanroom with double sterile barrier and
- 06
Distribution via own locations and distributors
Materials and Surface Treatments
Titanium alloy Ti 6Al 4V ELI (Grade 23)
Biocompatible alloy used for all Biotec implants with high strength, chemical stability and nearly complete bone integration.
Titanium dioxide coating
Thin layer of pure titanium dioxide on the implant surface.
Calcium phosphate (RBM blast treatment)
Biocompatible surface treatment to increase the implant surface area and improve bone contact.
Locations
Kassel
DEHeadquarters, development and manufacturing
- Materials
- Ti 6Al 4V ELI (Grade 23)
- Class 7 cleanroom (ISO 14644) for packaging
- Scanning electron microscope (SEM) for testing
Mooresville, NC
USMain Office and Manufacturing (as stated by the website, contradicting the German location)
Bucharest
ROSales (Biotec implant swiss srl)
Delhi
INSales (Suvsar Enterprises)
La Mesa, CA
USSales (Biotec implant INC)
Phnom Penh
KHSales (Violet Dental supply)
Niscemi (CL)
ITSales (Biotec implant dental italia s.a.s)
Istanbul/Esenyurt
TRSales (Atlantic Co.)
Aleppo
SYSales (Khaiata Co.)
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture of dental implant systems (Conical Connection B1, Internal Hex, Internal Hex 2.0Assembly | – | – | – | – | Ti 6Al 4V ELI (Grade 23) |
| RBM surface treatment (resorbable blast media, calcium phosphate) and titanium acid coatingSurface | – | – | – | – | Ti 6Al 4V ELI, Calcium phosphate, Titanium dioxide (TiO2) |
| CAD/CAM restoration (digital solutions)Engineering | – | – | – | – | – |
| Packaging in an ISO Class 7 cleanroom (double sterile barrier system, 3-year sterility)Assembly | – | – | – | – | Ti 6Al 4V ELI |
| Testing: SEM examinations as well as static and cyclic load tests (CIM, SPR, SPTT)Testing | – | – | – | – | Ti 6Al 4V ELI |
| Manufacture of surgical instruments, drills, surgical kits, prosthetics and biomaterialsEngineering | – | – | – | – | – |
2 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Scanning electron microscope (SEM) for testing | – | – | – | – | German production site |
| Class 7 cleanroom (ISO 14644) for packaging | – | – | – | – | German production site |
Additional services
Quality and Certification
Manufacturing is carried out in accordance with ISO 13485 and ISO 9001 as well as the Medical Device Directive 93/42/EEC with CE marking (certificate no. 14 0725 CE). Testing includes SEM examinations (scanning electron microscopy) as well as static and cyclic load tests on CIM, SPR and SPTT implants; packaging takes place in a Class 7 cleanroom (ISO 14644) with a double sterile barrier, batch documentation and a three-year sterility guarantee.
| Evidence | Kassel |
|---|---|
| ISO 9001 | |
| ISO 13485 | |
| CE 1023 (MDD 93/42/EEC) | |
| Class 7 cleanroom (ISO 14644) | |
| SEM testing and load tests |
Company History
- 2005
Founding of the Biotec Implant Company; insourcing of medical and dental materials for other medical companies worldwide.
- 2012
After seven years of materials manufacturing, start of own dental production with the implant lines SPR, ARC and CIM.
- 2013
Expansion with additional implants and features: ARP, SPTT, SPR and CIM.
- 2015
Introduction of the N1 implant design.
- 2017
Introduction of Zygomatic and Pterygoid implants.
- 2018
Introduction of the B1 implant.
- 2019
Sale of the first of one million Biotec implant products.