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Sign in to claim this brandSpecialites Septodont
US
Last updated May 23, 2026
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Catalogue (113)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ultra Safety Plus Twist 27G Long | 01N4472 | FDA UDI | Class II | Active |
| SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on | 01C4001 | FDA UDI | Class I | Active |
| Biodentine XP 500 | 01C0720 | FDA UDI | Class II | Active |
| Septodont Multi-Use Dispenser | 01C2056 | FDA UDI | Class I | Active |
| Isodan | 01S0100 | FDA UDI | Class II | Active |
| SeptoDiscs Refill:1/2” 50 assorted abrasive discs | 01C4002 | FDA UDI | Class I | Active |
| Ultra Safety Plus Ster Single Use Handle | 01N3400 | FDA UDI | Class II | Active |
| Safety Plus Handles | 01N3000 | FDA UDI | Class II | Active |
| SeptoWheels PX Kit: 12 wheels + 1 mandrel snap on | 01C4000 | FDA UDI | Class I | Active |
| Endosolv E | 01E0260 | FDA UDI | Class II | Active |
| Septoject 27g Long | 01N1272 | FDA UDI | Class I | Active |
| Racegel | 01C0500 | FDA UDI | U | Unknown |
| Ultra Safety Plus Twist 30G Short | 01N4401 | FDA UDI | Class II | Active |
| Ultra Safety Plus Twist 27G Short | 01N4571 | FDA UDI | Class II | Unknown |
| SeptoMatrix Sectional Refill: 1 reinforced ring Hard+8 tips | 01C4012 | FDA UDI | Class I | Active |
| Plastalgin | 01C1000 | FDA UDI | Class II | Active |
| Evolution Needles 30 G X-Short | 01N1650 | FDA UDI | Class I | Active |
| SeptoFipo Strips , box of 100, 2.5mm | 01C4038 | FDA UDI | Class I | Active |
| Evolution Needles 27g Short | 01N1600 | FDA UDI | Class I | Active |
| Biodentine | 01C0600 | FDA UDI | Class II | Active |
| SeptoWedges Refill: 100 wooden wedges n°3-red | 01C4023 | FDA UDI | Class I | Active |
| SeptoFipo Strips, box of 100, 4mm | 01C4039 | FDA UDI | Class I | Active |
| SeptoWedges Refill: 100 wooden wedges n°4-violet | 01C4024 | FDA UDI | Class I | Active |
| Ultra Safety Plus Twist kit 27G Long | 01N4572 | FDA UDI | Class II | Unknown |
| Pharmaethyl Spray | 01T0100 | FDA UDI | Class II | Active |
| Ultra Safety Plus Twist kit 25G Long | 01N4552 | FDA UDI | Class II | Unknown |
| Ultra Safety Plus Twist 25G Long | 01N4452 | FDA UDI | Class I | Active |
| Septoject 30g X-Short | 01N1300 | FDA UDI | Class I | Active |
| Orasoothe Oral Coating Rinse 4oz – Hygiene | 01S0630 | FDA UDI | Class I | Active |
| Ultra Safety Plus Twist 27G Short | 01N4471 | FDA UDI | Class II | Active |
| SeptoWedges Refill: 100 Asst. wooden wedges | 01C4020 | FDA UDI | Class I | Active |
| SeptoMatrix Sectional Refill: 50 medium matrices | 01C4016 | FDA UDI | Class I | Active |
| R.T.R. Syringe | 01S0500 | FDA UDI | Class II | Active |
| Septoject 25g Long | 01N1252 | FDA UDI | Class I | Active |
| SeptoDiscs Refill:1/2” 50 medium abrasive discs | 01C4004 | FDA UDI | Class I | Active |
| Endosolv | 01E0400 | FDA UDI | Class II | Active |
| BioRoot Flow-0.5 g | 01E0500 | FDA UDI | Class II | Active |
| Septalloy Ng50 - 2 Spill | 01C1550 | FDA UDI | Class II | Active |
| Orasoothe Oral Coating Rinse 4oz – Professional | 01S0620 | FDA UDI | Class I | Active |
| SeptoMatrix Sectional Refill: 50 assorted matrices | 01C4014 | FDA UDI | Class I | Active |
| Ultra Safety Plus Twist Reuseable handle | 01N3100 | FDA UDI | Class II | Active |
| Septalloy Ng50 - 1 Spill | 01C1500 | FDA UDI | Class II | Active |
| Endosolv E | K980633 | FDA 510(k) | Class II | Active |
| Cimpat S Dental Cement | K915467 | FDA 510(k) | Class II | Active |
| Isodan | K010415 | FDA 510(k) | Class II | Active |
| Septoject Sterile Disposable Injection Needle | K851524 | EUDAMEDFDA 510(k) | Class I | Active |
| Securalloy | K982671 | FDA 510(k) | Class II | Active |
| Septopack Temporary Filling | K915466 | FDA 510(k) | Class II | Active |
| Safety Plus Dental Injection Needle | K913573 | FDA 510(k) | Class I | Active |
| Cyanodont Dental Cement | K901082 | FDA 510(k) | Class II | Active |
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