Pure Global
Pure Global
๐Ÿ‡จ๐Ÿ‡ดColombia Dental Devices Medical Device Registration

Register Your Dental Device in Colombia

Implants, instruments, imaging systems, materialsโ€”streamlined INVIMA registration for the dental industry.

See Pricing

Free consultation โ€ข No commitment required

60-180

Days to Market

500+

Devices Registered

60-80%

Cost Savings

5yr

Registration Validity

Dental Devices Span All Risk Classes

Specialized devices need specialized expertise

Wide Risk Range

From Class I instruments to Class IV implants, dental products require different registration pathways.

Material Biocompatibility

Dental implants and restorative materials need extensive biocompatibility and long-term safety data.

Manufacturing Standards

INVIMA requires ISO 13485 compliance, often with ISO 22674 for dental alloys and materials.

The Solution

We Specialize in Dental Devices

Pure Global experts know your device category inside out

Deep Category Expertise

Full-range dental device registration (Class I-IV)

Technical Documentation Excellence

Clinical evidence compilation for dental implants

Proven Registration Track Record

Biocompatibility documentation for dental materials

Ongoing Compliance Support

Dental imaging and diagnostic device expertise

How It Works

1

Free Consultation

Share your device details. We'll confirm classification, assess your documentation, and provide an exact quote.

2

Expert Dossier Preparation

Our regulatory specialists prepare your complete submission with deep specialty knowledge.

3

Submission & Management

We submit on your behalf and manage the entire review process, including deficiency responses.

4

Market Your Device

Receive your registration. Your device is legally marketable for 10 years.

Trusted by Leading Dental Device Companies

Licensed Registration Holder
15+ Years Experience
Category Specialists
Local Office
โ€œPure Global registered our complete dental implant line in Colombia. Their understanding of dental-specific requirements saved us months.โ€

Dr. Maria Santos

Regulatory Director, DentaPro Implants

Transparent Pricing

Complete service, no hidden fees

Starting from

Starting from $2,000/year

Based on device class and complexitySave 60-80%

Ready to Register Your Dental Device?

Get a free consultation with our regulatory experts. We'll assess your device and provide an honest timeline and quote.

Free consultation No hidden fees Response within 24h
Pure Global

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