Question 1

What does Biodenta Swiss AG manufacture?

Accepted Answer

Biodenta Swiss AG manufactures dental implant suprastructures (both permanent and temporary, preformed), surgical drill guides (single-use), two-piece screw endosteal dental implants, dental implant abutment analogs for intraoral scanning (single-use), and dental prosthesis/implant abutment screws.

These devices are classified as Class I, Class II, and Class IIb and are listed in Eudamed, FDA 510(k), and FDA UDI databases. The company is based in Switzerland (CH).

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Biodenta Swiss AG based?

Accepted Answer

Biodenta Swiss AG is based in Switzerland, as indicated by the country code CH in the device data. This establishes the company’s geographic location without implying any regulatory approval or certification of the company itself.

Question 3

Which regulatory registries list devices from Biodenta Swiss AG?

Accepted Answer

Devices from Biodenta Swiss AG are listed in Eudamed, the FDA 510(k) database, and the FDA UDI database. These are the only registries explicitly named in the provided data, and listing in these systems reflects device registration, not company approval.

Question 4

How are the devices manufactured by Biodenta Swiss AG classified?

Accepted Answer

The devices manufactured by Biodenta Swiss AG are classified as Class I, Class II, and Class IIb. This classification reflects the risk-based regulatory categorization of the individual device types, such as surgical drill guides or implant abutments, and does not imply that the company as a whole holds any classification or approval.

Device	Model / Reference	Registries	Class	Status
Biodenta Customized Abutment - Titanium	K151295	FDA 510(k)	Class II	Active
Biodenta Dental Implant System - Bone Level	K111003	FDA 510(k)	Class II	Active
Biodenta Dental Implant System- Bone Level Tapered	K123415	FDA 510(k)	Class II	Active
Biodenta Dental Implant System - Abutments	K122559	FDA 510(k)	Class II	Active
Biodenta Customized Abutment	K110778	FDA 510(k)	Class II	Active
Universal Analog	CAD-UAOHMA	EUDAMED	Class I	Active
Scan Body	CAD-SBATOS3545	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UANANP	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UASMBNCRC	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAMUBW	EUDAMED	Class I	Active
Scan Body	CAD-SBSBLRC	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-SBNBWPI	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UASBLRC	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UA3ILP	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UA3ICI41	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAOTS35	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UABHI45	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UABHMU	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-TSBBDBLB2S	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-SBNBNPI	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-SB3IC34	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAATOS4550	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAATOS3540	EUDAMEDFDA UDI	Class I	Active
Closure Screw	CS-B0018B2C	EUDAMEDFDA UDI	Class IIb	Active
Universal Analog	CAD-UANRNP	EUDAMED	Class I	Active
Universal Analog	CAD-UANR60	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UASSORN	EUDAMED	Class I	Active
Universal Analog	CAD-UABBLB0	EUDAMED	Class I	Active
Scan Body	CAD-SBZTSV35	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAZSV45	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UA3ICI60	EUDAMEDFDA UDI	Class I	Active
Scan Body	CAD-SBOTS45	EUDAMEDFDA UDI	Class I	Active
Angle Abutment	AB-B040GH2A	EUDAMEDFDA UDI	Class IIb	Active
Scanbody	CAD-TSBBDBLB0S	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-SBNBANP	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UANRWP	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UASBLNC	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UANARP	EUDAMEDFDA UDI	Class I	Active
Scanbody	CAD-SBNB60I	EUDAMEDFDA UDI	Class I	Active
Dental Implant (Bone Level Tapered)	I-PA41B2L10A	EUDAMEDFDA UDI	Class IIb	Active
Scan Body	CAD-SBBHI57	EUDAMED	Class I	Active
Universal Analog	CAD-UABBLB1	EUDAMED	Class I	Active
Scan Body	CAD-SBZTSV45	EUDAMEDFDA UDI	Class I	Active
Scan Body	CAD-SBOTS35	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UABHI57	EUDAMEDFDA UDI	Class I	Active
Healing Abutment	HA-B2040B1H	EUDAMEDFDA UDI	Class IIb	Active
Scan Body	CAD-SBATOS4550	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UASSOWN	EUDAMED	Class I	Active
Universal Analog	CAD-UAZACTRTA	EUDAMEDFDA UDI	Class I	Active
Universal Analog	CAD-UAZSV57	EUDAMEDFDA UDI	Class I	Active

Biodenta Swiss AG

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