Bio3 Implants GmbH Warranty, Returns, and Exchange Policy

 

Bio3 Implants GmbH Warranty Policy

1. General Provisions
Bio3 Implants GmbH, registered in Germany, provides a voluntary lifetime warranty on dental implants manufactured by our company, in accordance with the terms of this warranty policy.

The warranty exclusively covers the dental implant itself and does not represent a legal obligation but is granted at the manufacturer's discretion in the interest of product quality.

2. Scope of Warranty
This warranty exclusively covers the replacement of the dental implant and applies for the entire lifetime of the product.

Replacement will occur if the implant failure is due to a confirmed manufacturing defect or disintegration occurs under proper clinical use.

The warranty explicitly excludes:

  • Implant removal costs;
  • Costs for inserting a new implant;
  • Services of dentists and surgeons;
  • Costs of clinical procedures and follow-up treatments;
  • Costs arising from temporary incapacity for work or indirect damages;
  • Replacement of abutments, superstructures, temporary components, surgical instruments, and accessories.

3. Warranty Conditions
A warranty claim must be submitted in writing using the forms approved by Bio3 Implants GmbH and transmitted via an authorized dealer or directly to Bio3 Implants GmbH.

Forms and instructions for completion are available upon request or in the documents provided by the dealer.

The following documents are required to assert the warranty:

  • Product information (batch number, date of insertion, proof of purchase);
  • Proof of proper adherence to the surgical protocol during implantation;
  • X-rays or other medical documents as requested by the manufacturer.

The warranty is only valid under the following conditions:

  • The implantation was performed by a qualified professional;
  • Only original components recommended by the manufacturer were used;
  • The insertion and aftercare protocol was followed.

Warranty claims may only be submitted by the treating physician (dentist) or an authorized dealer with a contractual relationship to Bio3 Implants GmbH.

Direct applications from patients will not be considered.

4. Replacement Procedure
The review of a warranty claim will be carried out according to Bio3 Implants GmbH's internal procedure for complaint and return processing.

The current version is available upon request or accessible to authorized partners.

Return of disintegrated implants
In the event of implant disintegration, and if the necessary proof is provided and the warranty conditions are met, the implant will be replaced.

Bio3 Implants GmbH reserves the right to request the physical return of the disintegrated implant for analysis and determination of the cause.

The return shipment must be in agreed sterile packaging and comply with transport regulations for medical devices.

The decision on whether a warranty case is recognized will be made by the Quality Department of Bio3 Implants GmbH after evaluation.

After review and decision, Bio3 Implants will provide:
✓ an equivalent new implant free of charge;
✓ delivery will be direct or through an official dealer.

5. Limitations
This warranty does not apply if:

  • the damage was caused by trauma, incorrect insertion, overloading of the construction, or non-compliance with the medical protocol;
  • third-party components were used;
  • the product's expiration date was exceeded at the time of insertion;
  • the product was used outside the indications and instructions provided by the manufacturer.

6. Final Provisions
This voluntary warranty does not restrict the statutory consumer rights according to § 437 et seq. of the German Civil Code (BGB), including the right to supplementary performance, replacement, reduction, or rescission in the event of product defects.

7. Return and Exchange Policy

Products purchased as part of special promotions, special offers, or individually agreed conditions are generally excluded from return and exchange.

An exchange can only be made in justified individual cases and only after prior written consent from Bio3 Implants GmbH. There is no right to an exchange (§ 311 para. 1 BGB).

An approved exchange is exclusively permitted within the same product category. The exchange will only be for an identical product that corresponds in function and intended purpose to the originally purchased item.

Even if consent has been granted, an exchange is only possible under the following conditions:

  • The goods are unused and have not been clinically applied;
  • The original packaging is unopened, undamaged, and complete;
  • The product has a remaining shelf life (expiration date) of at least 10 months at the time of return;
  • The return is made in compliance with the applicable transport and hygiene regulations for medical devices according to Regulation (EU) 2017/745 (MDR).

The decision regarding the approval of an exchange, as well as the specific modalities of processing, lies at the sole discretion of Bio3 Implants GmbH.

This regulation applies exclusively to voluntary services provided by Bio3 Implants GmbH and does not affect the buyer's statutory rights, particularly in the presence of defects according to §§ 437 et seq. BGB, as well as the duty to inspect and give notice of defects according to § 377 HGB.