Organization name

CeraRoot SL

SRN

ES-MF-000000251

Manufacturer status

Active

12 warnings recorded — scroll inside the panel to see all entries.

• Consult instructions for use
• Do not re-use

  CeraRoot® dental implant is sterile and for single use only.

• Do not resterilize

  CeraRoot® dental implant is sterile and for single use only.

• Do not use if package is damaged
• Do not use past indicated date

  Use of dental implant after the expiry date might lead to infections.

• MR SAFE

  The raw material of dental implant is ceramic and this has no interaction with the magnetic forces associated with MR.

• Product must be secured against aspiration when handled intraorally. Aspiration of product may lead to infection or unplanned physical injury. Avoid approaching the proximity of the mandibular nerve channel during implant bed preparation and implant insertion. Nerve damage may result in anaesthesia, paresthesia and dysesthesia.

  OTHER

• Do not exceed 35 Ncm of torque during the implant insertion to avoid bone and/or implant fractures.

  OTHER

• No grinding of any part of the implant is allowed since the conditions of this cannot be controlled by the manufacturer. If for any reason the user has to grind the implant this has to be a minor adjustment and always use fine diamond burs (red or yellow) with water refrigeration. Grinding can lead to a reduction in structural integrity of the implant material, thus causing implant fracture during normal occlusal loading. There is also the risk of bone necrosis due to excessive heat which is generated during the grinding of ceramics.

  OTHER

• Inadequate bone volume and/or quality might lead to insufficient primary stability and consequently mobility, and even loss of the implant. Should the bone volume be insufficient to guarantee primary stability, follow a two-stage surgical approach by regenerating the bone tissue first, prior to implant insertion.

  OTHER

• To use CeraRoot® dental implants is recommended to be trained by a professional with experience in the system. CeraRoot® implants must be placed only by dentists, doctors or surgeons that have received specific training and have advanced experience in oral surgery, periodontics, implantology and prosthodontics. This is especially important because the surgical implantation technique for CeraRoot® implants is complex. CeraRoot® Training Team offers periodic training courses and practical sessions for the users.

  OTHER

• The patient should have an absence of local and systemic contraindications, normal healing capacity good oral hygiene and presence of healing capacity good oral hygiene and presence of healthy and sufficient bone. The placement of dental implants should not be done in patients with health problems, disease or any physical or psychological condition to which oral surgery may be contraindicated.

  OTHER

Primary placement in Spain; available across 31 countries total.

Trade name

CeraRoot® Implant 21, L 12

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

08435453900089

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

84354539CREC

Reference / catalog number

210.012

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Implant CeraRoot 21:12/4.1-4.8 -Size L= 12 mm. Indicated for UPPER CENTRAL INCISORS AND CUSPIDS. One-piece zirconia dental Implant including abutment.

Additional information URL

https://ifu.ceraroot.com/eifu

Clinical sizes

• 12 MU50
• 4.1–4.8 MU50

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• P01020101DENTAL IMPLANTS

• Class IIb medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.