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- · Impression of inlay, onlay, crown, bridge, and veneer preparations - · Functional impressions

The polyether impression material Permadyne consists of the two material components lightbodied consistency and heavy-bodied consistency. It's classified as impression materials (21 CFR 872.3660) because it's intended to reproduce the structure of a patient's teeth and qums. Permadyne is a hand mixed (base paste/catalyst paste) impression material used in one step technique. Thereby Permadyne – Light Bodied Consistency is used as wash material in combination with Permadyne – Heavy Bodied Consistency as tray material. The mixing ratio is 7 volumes base paste :1 volume catalyst paste. Permadyne – Light Bodied Consistency is a light-bodied polyether impression material. The base paste is blueish colored and the catalyst paste reddish colored. Permadyne - Heavy Bodied Consistency is a heavy-bodied polyether impression material. The base paste is salmon colored and the catalyst paste reddish colored.

Use of Suglue 3 in Adhesive Mode with ADH19 ·Final cementation of all-ceramic or metal Maryland bridges and 3-unit inlay/onlay bridges ·Final cementation of all-ceramic or composite veneers and occlusal veneers (tabletops) Use of Suglue 3 in Adhesive Mode with ADH19 or in Self-Adhesive Mode ·Final cementation of all-ceramic, composite, or metal inlays and onlays, crowns, and bridges ·Final cementation of posts made of ceramic, glass fiber-reinforced composite or metal, and screws ·Final cementation of all-ceramic, composite, or metal restorations on implant abutments

Suglue 3 is a dual-curing universal cement that is used for both adhesive and self-adhesive cementation of indirect restorations and posts, whereas RelyX Unicem 2 Automix is a selfadhesive cement and RelyX Ultimate is an adhesive cement. New redox initiator system provides improved bond strength to tooth structure, especially dentin. Changed characteristics allow easier excess removal. Increased radioopacity facilitates clinicians to see the Suglue 3 in radiographs as well as tooth like fluorescence for an esthetic appearance, especially in the anterior region. Suglue 3 is used in combination with ADH19 (dental adhesive, product of 3M Deutschland GmbH) for adhesive cementation. ADH19 adhesive is self-etching. Optionally, the adhesive strength can be enhanced further through additional etching of the tooth structure with Scotchbond Universal Etchant (product of 3M Deutschland GmbH). Standard cases as well as post cementations can be solved securely and efficiently when Suglue 3 is used in selfadhesive mode.

Direct Indications: · Bonding for all methacrylate-based light-, dual-, and self-cure composite or compomer filling materials ·Root surface desensitization · Bonding of methacrylate-based fissure sealants · Protective varnish for glass ionomer fillings ·Repair of composite and compomer fillings · Sealing of cavities prior to placement of amalgam restorations Indirect Indications: · Cementation of indirect restoration with Suglue 3 and other resin cements (follow applicable Instructions for Use) · Bonding for all methacrylate-based light-, self-, and dual-cure core build-up materials and cements · Cementation of veneers when combined with RelyX Veneer Cement · Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer •Sealing of cavities and preparation of tooth stumps prior to temporary cementation of indirect restorations

ADH19 is a one-component dental adhesive that is based on the chemistry of Scotchbond Universal (by 3M Deutschland GmbH, K110302, cleared as ADHESIVE EXL-759). It can be used in a self-etch mode, selective enamel etch mode or in a total-etch mode for both direct and indirect dental restorative procedures. It is intended to bond methacrylate-based restorative, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (metals, glass ceramics, alumina and zirconia). The primary use will be with lightcured materials, however it will have the capability to also bond self- or dual-cure composite and cement materials. In contrast to Scotchbond Universal, no separate Dual Cure Activator will be necessary in this case.

· Impressions of inlay, onlay, veneer, crown, and bridge preparations · Fixation and implant impressions RAPID HB, MB and LB are especially suitable for taking impressions of single-unit and double-unit preparations.

Rapid HB, Rapid LB and Rapid MB are a group of polyether impression materials of heavy, light and medium consistency used by dental professionals individually or in combination. Rapid HB and Rapid MB are mixed in the Pentamix mixing device, while Rapid LB can be applied directly using the Garant dispenser. Rapid HB is a heavy bodied hydrophilic impression material used in one step technique. Thereby Rapid HB is used in combination with the light consistency wash material Rapid LB. Rapid HB is reddish-violet colored. Rapid LB is a light bodied hydrophilic impression material used in one step technique. Thereby Rapid LB is used in combination with the higher consistency tray material Rapid LB is apple green colored. Rapid MB is a medium bodied hydrophilic impression material used in mono-phase technique (Rapid MB as syringing and as tray material) and in one step technique (Rapid LB as syringing and Rapid MB as tray material). Rapid MB is blueish-violet colored.

· Single crowns · Bridges with a maximum of one pontic between two crowns · Inlays, onlays, and veneers

XP202 zirconia blanks are used for the fabrication of esthetic zirconia restorations. The blanks are available in various heights and shades based on the Vita™ Classical shade guide. After sintering, restorations display a gradient shading and inherent fluorescence. The restorations are designed using dental CAD software and the data is converted into milling paths by CAM software. The blanks can be processed in milling units suitable for pre-sintered zirconia. Milled restorations must be final sintered in a furnace suitable for zirconia per the cycle designated for XP202.

- Linings for single-surface and multiple-surface composite fillings - Core build-up prior to crown placement - Primary tooth fillings - Stress bearing Class I restorations with at least one additional support outside of the filling area - Stress bearing Class II restorations when the isthmus is less than half of the intercuspal distance and with at least one additional support outside of the filling area - Cervical fillings, if aesthetics is not the prime consideration - Single-surface and multiple-surface temporary fillings - Fissure sealing

Ketac Universal Aplicap is a radiopaque glass ionomer restorative delivered in capsules used for bulk fillings. It can be applied without lining; releases fluoride ions and is available in various shades corresponding to the Vita™ Classical color system.

· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains · Professional cleaning of teeth including patients with dentin hypersensitivity · Treatment of dentin hypersensitivity by blockage of the dentin tubules · Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants · For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth · For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth

Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices. Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.

Fabrication of temporary crowns, bridges, inlays, onlays, and veneers Fabrication of long-lasting temporary restorations . . Lining material for prefabricated temporary crowns made of composite (e.g., ProtempTM Crown) and metal (e.g., Iso-Form crowns)

SuPro 100 is classified as temporary crown and bridge resin (21 C.F.R. § 872.3770, Class II device). As its predicate device TempXN28 (K073296, by 3M Deutschland GmbH - Germany), SuPro 100 is a composite material based on multifunctional methacrylates esters, therefore, both TempXN28 and SuPro 100 as two-component system have filling material-like properties. As TempXN28, Supro 100 will be available in Garant™ mixing and dispensing system (by 3M Deutschland GmbH, Germany).

- Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants - For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only - For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only Calculi and tartar cannot be removed with Clinpro Prophy Powder.

Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.

- Impressions for the production of temporary restorations . - . All types of preliminary impressions - . Impressions of the opposing jaw - Impressions for orthodontic models .

Flash AR and Flash AR Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used. Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).