Question 1

What types of dental devices does Schütz Dental GmbH manufacture?

Accepted Answer

Schütz Dental GmbH specializes in dental materials used for appliance fabrication and restorative procedures. Their product range includes ceramic and resin-based dentin and opaque materials for dental appliances, dental composites for fillings, repair kits for ceramic restorations, and dental bridges made from polymers, metal-polymer combinations, as well as casting and brazing alloys. These materials are designed to support dental technicians and practitioners in creating durable, functional, and aesthetically pleasing dental restorations.

Question 2

Where is Schütz Dental GmbH based, and what does this mean for their regulatory oversight?

Accepted Answer

Schütz Dental GmbH is based in the United States. Since their devices are regulated under FDA jurisdiction, they must comply with U.S. medical device regulations, including classification under the FDA’s risk-based system. The company’s products fall under Class II, which typically requires premarket notification (510(k)) or other regulatory pathways to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution in the U.S.

Question 3

Are Schütz Dental GmbH’s devices listed in any regulatory registries, and why does this matter?

Accepted Answer

Yes, Schütz Dental GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to quickly identify and verify the specific devices in use. Listing in the UDI database is mandatory for Class II devices in the U.S. and helps streamline recalls, post-market surveillance, and compliance efforts.

Question 4

How are Schütz Dental GmbH’s dental devices classified under FDA regulations, and what does this classification imply?

Accepted Answer

All of Schütz Dental GmbH’s listed devices are classified as Class II under FDA regulations. This classification indicates that while the devices pose a moderate risk, they require special controls beyond general controls (like good manufacturing practices) to ensure safety and effectiveness. For Class II devices, manufacturers typically submit a 510(k) premarket notification to demonstrate that their device is substantially equivalent to a legally marketed predicate device, ensuring it meets applicable performance standards and regulatory requirements.

Device	Model / Reference	Registries	Class	Status
Tizian Ceramic Shoulder Fluid SM F	624878	FDA UDI	Class II	Active
FuturaJet Liquid	650062	FDA UDI	Class II	Active
NanoPaq A 3.5, 0.3 g	234613	FDA UDI	Class II	Active
FuturaPress LT Liquid	650161	FDA UDI	Class II	Active
Tizian Ceramic Dentin B2	624769	FDA UDI	Class II	Active
Capo Hybrid A 3, 0.3 g	232122	FDA UDI	Class II	Active
Capo Slow Flow capsules clear, 20 x 0.25	232115	FDA UDI	Class II	Active
FuturaPress LT Pink Opaque	650112	FDA UDI	Class II	Active
Tizian Ceramic Opaque Dentin A4	624742	FDA UDI	Class II	Active
NanoPaq Fillis Set	234600	FDA UDI	Class II	Active
EL-FORM Electroforming Liquid, 1000 ml	625010	FDA UDI	Class II	Unknown
Tizian Ceramic Opaquer D4	624716	FDA UDI	Class II	Active
Tizian Ceramic Opaque Dentin C4	624750	FDA UDI	Class II	Active
Tizian Ceramic Opaque Dentin A3	624672	FDA UDI	Class II	Active
Tizian Ceramic Incisal S4	624762	FDA UDI	Class II	Active
NanoPaq Opakdentin B 2, 4 g	234533	FDA UDI	Class II	Active
Tizian Ceramic Transparent Grey T5	624690	FDA UDI	Class II	Active
FuturAcryl 2000 Pink	650513	FDA UDI	Class II	Active
Tizian Ceramic Liner 1	624792	FDA UDI	Class II	Active
Tizian Ceramic Stain Shade B	624867	FDA UDI	Class II	Active
Capo Slow Flow B 1, 2 g	232065	FDA UDI	Class II	Active
Capo Flow A 3, 2 g	234303	FDA UDI	Class II	Active
Tizian Ceramic Transparent Tclear TC	624686	FDA UDI	Class II	Active
Tizian Ceramic Dentin A3.5	624766	FDA UDI	Class II	Active
FuturAcryl 2000 Pink Opaque	650512	FDA UDI	Class II	Active
Tizian Ceramic Liner Fluid red LF	624797	FDA UDI	Class II	Active
Capo Hybrid B 2, 5 g	232024	FDA UDI	Class II	Active
EL-FORM Brightener, 50 ml	625021	FDA UDI	Class II	Active
FuturaSelf Pink veined	650614	FDA UDI	Class II	Active
NanoPaq Flow A 3.5, 2 g	234713	FDA UDI	Class II	Active
Capo Natural C 2, 4 g	232047	FDA UDI	Class II	Active
EL-FORM Brightener, 50 ml	625021	FDA UDI	Class II	Unknown
Tizian Ceramic Opaquer	624709	FDA UDI	Class II	Active
EL-FORM Electroforming Liquid, 1000 ml	625010	FDA UDI	Class II	Active
Capo Natural Incisal clear, 4 g	232050	FDA UDI	Class II	Active
Capo Natural B 3, 4 g	232046	FDA UDI	Class II	Active
FuturaSelf Pink	650613	FDA UDI	Class II	Active
FuturaPress LT Pink	650123	FDA UDI	Class II	Active
Tizian Blank Titanium Grade 4, 98 x 15 mm	624490	FDA UDI	Class II	Active
Tizian Ceramic Opaque Dentin B3	624745	FDA UDI	Class II	Active
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow	K151399	FDA 510(k)	Class II	Active
Sebond Pink Light 5g, Sebond Pink Dark 5g, Sebond Smart 5ml, Sebond Grip 3g, Models 644090, 644091, 640066, 644092	K051050	FDA 510(k)	Class II	Active
Tizian Ceramic, Flow, Plate, Fix & Zr Blanks	K071010	FDA 510(k)	Class II	Active
Tizian Blank, Tizian Zirconium Reinforced Composite Blank, Tizian Color Blank, Tizian Blank Occlusal, Tizian Blank Trans	K133268	FDA 510(k)	Class II	Active
Futurapress Lt, N And Hp, Futurajet, Futuraself, Futuragen And Futuracryl 2000	K052073	FDA 510(k)	Class II	Active
Reveneer Ceramic Repair System	K052189	FDA 510(k)	Class II	Active

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