Manufacturer registered with FDA
Rhein'83 Srl
BOLOGNA, Italy. Lists 8 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 633
- 510(k) clearances
- 42004–2018
- Markets registered in
- 11268 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Rhein'83 Srl as the manufacturer or the registration holder of a device.
RegisteredHome: ItalyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Rhein'83 Srl | 4 clearances | 2004–2018 | Below |
| Colombia | INVIMA | Manufacturer | RHEIN 83 S.R.LRHEIN 83 S.R.L. · RHEIN 83 SRL | 151 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | RHEIN 83 S.r.l.RHEIN 83 S.r.l · Rhein 83 S.r.l. · +2 | 24 | 1999–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Rhein 83 S.r.l. | 22 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | RHEIN 83 S.R.L. | 22 | 2022–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | RHEIN 83 S.R.L. | 19 | 2011–2014 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Rhein83 Srl | 18 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Rhein 83 Srl | 4 | 2019–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | RHEIN 83 S.R.LRHEIN 83 S.R.L. · Rhein 83 S.r.l. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | RHEIN 83 S.R.L.RHEIN83 S.R.L. | 3 | 2016–2023 | Pure Global AI |
| Japan | PMDA | Registration holder | ＲＨＥＩＮ ８３ Ｓ．ｒ．ｌ． | 2 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Rhein'83 Srl currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | KEF44SMD331 ALL ON FOUR EASY FIX SEVEN ø3,3 h.1KEF46NAC354 ALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4KEF46OCT33 ALL ON FOUR EASY FIX synOCTA O/I h.3,3KEF46PRK333 ALL ON FOUR EASY FIX PRE.KOHNO H. 3KEF46PRK334 ALL ON FOUR EASY FIX PRE.KOHNO H. 4KEF46TEK42 ALL ON FOUR EASY FIX IN-KONE TEKKA H 2KEF49AS4NC1 ALL ON FOUR EASY FIX - ASTRA ø 4 h.1KEF49AS4NC3 ALL ON FOUR EASY FIX - ASTRA ø 4 h.3KEF49KEF45 ALL ON FOUR EASY FIX IN-KONE Tekka h.5KEF49NAC354 ALL ON FOUR EASY FIX YOUSE V 3,3/3,75h.4 320 moreKEF49PRK331 ALL ON FOUR EASY FIX PREMIUM KHONO ø 3,3KEF49PRK334 ALL ON FOUR EASY FIX PREMIUM KHONO ø 3,3KEF49SMD2 ALL ON FOUR EASY FIX MIS BioCom/SEVEN h2KEF49SMD3 ALL ON FOUR EASY FIX MIS BioCom/SEVEN h3KEF49SMD4 ALL ON FOUR EASY FIX MIS BioCom/SEVEN h4KEF49TEK44 ALL ON FOUR EASY FIX IN-KONE Tekka h.4KEF49TEK45 ALL ON FOUR EASY FIX IN-KONE Tekka h.5Z-EQ-131TN351 Equator Tri-Nex ø3.5 x 1mm KitZ-EQ-131TN352 Equator Tri-Nex ø3.5 x 2mm KitZ-EQ-131TN353 Equator Tri-Nex ø3.5 x 3mm KitZ-EQ-131TN354 Equator Tri-Nex ø3.5 x 4mm KitZ-EQ-131TN355 Equator Tri-Nex ø3.5 x 5mm KitZ-EQ-131TN356 Equator Tri-Nex ø3.5 x 6mm KitZ-EQ-131TN357 Equator Tri-Nex ø3.5 x 7mm KitZ-EQ-131TN431 Equator Tri-Nex ø4.3 x 1mm KitZ-EQ-131TN432 Equator Tri-Nex ø4.3 x 2mm KitZ-EQ-131TN433 Equator Tri-Nex ø4.3 x 3mm KitZ-EQ-131TN434 Equator Tri-Nex ø4.3 x 4mm KitZ-EQ-131TN435 Equator Tri-Nex ø4.3 x 5mm KitZ-EQ-131TN436 Equator Tri-Nex ø4.3 x 6mm KitZ-EQ-131TN437 Equator Tri-Nex ø4.3 x 7mm KitZ-EQ-131TN51 Equator Tri-Nex ø5 x 1mm KitZ-EQ-131TN52 Equator Tri-Nex ø5 x 2mm KitZ-EQ-131TN53 Equator Tri-Nex ø5 x 3mm KitZ-EQ-131TN54 Equator Tri-Nex ø5 x 4mm KitZ-EQ-131TN55 Equator Tri-Nex ø5 x 5mm KitZ-EQ-131TN56 Equator Tri-Nex ø5 x 6mm KitZ-EQ-131TN57 Equator Tri-Nex ø5 x 7mm KitZ-EQ-SBOX Retentive EQ Cap Set030AEV541 OT EQUATOR ASTRA EV ø5,4 h.1030AEV542 OT EQUATOR ASTRA EV ø5,4 h.2030AS4NC3-DIO DIO Implant UF-UFII Regular Int. Type030BLN1-IQ OT EQUATOR STRAUMANN BL NC h.1030BLN2-IQ OT EQUATOR STRAUMANN BL NC h.2030BLN3-IQ OT EQUATOR STRAUMANN BL NC h.3030BLN4-IQ OT EQUATOR STRAUMANN BL NC h.4030BLN5-IQ OT EQUATOR STRAUMANN BL NC h.5030BLN6-IQ OT EQUATOR STRAUMANN BL NC h.6030BLN7-IQ OT EQUATOR STRAUMANN BL NC h.7030BLR1-IQ OT EQUATOR STRAUMANN BL RC h.1030BLR2-IQ OT EQUATOR STRAUMANN BL RC h.2030BLR3-IQ OT EQUATOR STRAUMANN BL RC h.3030BLR4-IQ OT EQUATOR STRAUMANN BL RC h.4030BLR5-IQ OT EQUATOR STRAUMANN BL RC h.5030BLR6-IQ OT EQUATOR STRAUMANN BL RC h.6030BLR7-IQ OT EQUATOR STRAUMANN BL RC h.7030CCM6 OT EQUATOR NOVO COLOSSO CM h.6030CDT1-SM OT EQUATOR CSR030CDT2-SM OT EQUATOR CSR030CDT3-SM OT EQUATOR CSR030CDT4-SM OT EQUATOR CSR030CDT5-SM OT EQUATOR CSR030CDT6-SM OT EQUATOR CSR030CDT7-SM OT EQUATOR CSR030CDTN1-SM OT EQUATOR CSR030CDTN2-SM OT EQUATOR CSR030CDTN3-SM OT EQUATOR CSR030CDTN4-SM OT EQUATOR CSR030CDTN5-SM OT EQUATOR CSR030CDTN6-SM OT EQUATOR CSR030CDTN7-SM OT EQUATOR CSR030DIU33 OT EQUATOR DIO UF NARROW ø 3-3.3 h3030HEK1 OT EQUATOR HIOSSEN EK h.1030HEK2 OT EQUATOR HIOSSEN EK h.2030HEK3 OT EQUATOR HIOSSEN EK h.3030HEK4 OT EQUATOR HIOSSEN EK h.4030HEK5 OT EQUATOR HIOSSEN EK h.5030IDS1 MONCONE EQUATOR IDI CAM STD h.1030NEO33 OT EQUATOR NEOSS ø 3,25 h.3030NGM1-IQ OT EQUATOR NEODENT GM h.1030NGM2-IQ OT EQUATOR NEODENT GM h.2030NGM3-IQ OT EQUATOR NEODENT GM h.3030NGM4-IQ OT EQUATOR NEODENT GM h.4030NGM5-IQ OT EQUATOR NEODENT GM h.5030NGM6-IQ OT EQUATOR NEODENT GM h.6030NGM7-IQ OT EQUATOR NEODENT GM h.7030NIA31 OT EQUATOR NEO BIOTECH IS III ø 3,2 h.1030OMNP3 OT EQUATOR OMEGA IMPLANT NP h.3030ONK332-SM OT EQUATOR OUTLINK2030ONK333-SM OT EQUATOR OUTLINK2030ONK334-SM OT EQUATOR OUTLINK2030ONK335-SM OT EQUATOR OUTLINK2030ONK336-SM OT EQUATOR OUTLINK2030ONK337-SM OT EQUATOR OUTLINK2030ONK412-SM OT EQUATOR OUTLINK2030ONK413-SM OT EQUATOR OUTLINK2030ONK414-SM OT EQUATOR OUTLINK2030ONK415-SM OT EQUATOR OUTLINK2030ONK416-SM OT EQUATOR OUTLINK2030ONK417-SM OT EQUATOR OUTLINK2030OXC3 OT EQUATOR OXYIMPLANT h.3030POT01-MY OT ABUTMENT GH 1.5030POT02-MY OT ABUTMENT GH 3030POT03-MY OT ABUTMENT GH 4.5030POT04-MY OT ABUTMENT GH 6030PRP3305-SM OT EQUATOR COLLEX030PRP331-SM OT EQUATOR COLLEX030PRP332-SM OT EQUATOR COLLEX030PRP333-SM OT EQUATOR COLLEX030PRP334-SM OT EQUATOR COLLEX030PRP335-SM OT EQUATOR COLLEX030PRP336-SM OT EQUATOR COLLEX030PRP337-SM OT EQUATOR COLLEX030PRP381-SM OT EQUATOR COLLEX030PRP382-SM OT EQUATOR COLLEX030PRP383-SM OT EQUATOR COLLEX030PRP384-SM OT EQUATOR COLLEX030PRP385-SM OT EQUATOR COLLEX030PRP386-SM OT EQUATOR COLLEX030PRP387-SM OT EQUATOR COLLEX030SK14 MONC. OT EQUATOR SK1 ø 3,75-4-4,9 h.4030SRC1 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.1030SRC2 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.2030SRC3 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.3030SRC4 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.4030SRC5 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.5030SRC6 OT EQUATOR STRONG SW CM ø 3,5-4,3-5 h.6030TIR333 OT EQUATOR TiRADIX ø 3,3 h.3030YI05 OT EQUATOR YI030YI1 OT EQUATOR YI030YI2 OT EQUATOR YI030YI3 OT EQUATOR YI030YI4 OT EQUATOR YI030YI5 OT EQUATOR YI030YI6 OT EQUATOR YI030YI7 OT EQUATOR YI030YVN1 OT EQUATOR YV-N030YVN2 OT EQUATOR YV-N030YVN3 OT EQUATOR YV-N030YVN4 OT EQUATOR YV-N030YVN5 OT EQUATOR YV-N030YVN6 OT EQUATOR YV-N030YVN7 OT EQUATOR YV-N030YVR1 OT EQUATOR YV-R030YVR2 OT EQUATOR YV-R030YVR3 OT EQUATOR YV-R030YVR4 OT EQUATOR YV-R030YVR5 OT EQUATOR YV-R030YVR6 OT EQUATOR YV-R030YVR7 OT EQUATOR YV-R | 2016 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | A01MOG MOOSER BUR FOR PIVOT h7-9-10BROKEN SCREW EXTRACTOR KIT680ANP ESTRATTORE IMP. ADIN UNP ø 2,75680CAM5 ESTRATTORE IMP. CAMLOG ø 5680CAM6 ESTRATTORE IMP. CAMLOG ø 6680CV ESTRATTORE IMP. SCREW VENT680NAC35 ESTRATTORE IMP. NOBELACTIVE680NAC39 ESTRATTORE IMP. NOBELACTIVE680NAC5 ESTRATTORE IMP. NobelActive WP ø 5,5 | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | SPHERO FLEX AND BLOCK; OT EQUATOR PROFILE; | 2012 |
| All Precision AttachmentEGG · Class 1 | — | Maker | CA008-100 OT EQUATOR INOX BOX #100CA008-500 OT EQUATOR INOX BOX #500CA011-10 BOX ACCIAIO INOX NORMO #10CA011-100 BOX ACCIAIO INOX NORMO #100CA011-50 BOX INOX NORMO #50CA011-500 BOX INOX NORMO #500CA012-100 OT CAP INOX BOX MICRO #100CA012-50 OT CAP INOX BOX MICRO #50CA012-500 OT CAP INOX BOX MICRO #500CN001-500 PINK CAP NORMO #500 193 moreCN002-10 CLEAR CAP NORMO #10CN002-100 CLEAR CAP NORMO #100CN002-50 CLEAR CAP NORMO #50CN002-500 CLEAR CAP NORMO #500CN009-100 CLEAR CAP MICRO #100CN009-50 CLEAR CAP MICRO #50CN009-500 CLEAR CAP MICRO #500CN010-100 PINK CAP MICRO #100CN010-50 PINK CAP MICRO #50CN010-500 PINK CAP MICRO #500CN011-100 YELLOW CAP MICRO #100CN011-50 YELLOW CAP MICRO #50CN011-500 YELLOW CAP MICRO #500CN027-500 BLACK CAP NORMO FOR LAB #500CN031-500 GREEN CAP NORMO #500CN051-100 OT EQUATOR CLEAR CAP #100CN051-500 OT EQUATOR CLEAR CAP #500CN052-100 OT EQUATOR PINK CAP #100CN052-50 OT EQUATOR PINK CAP #50CN052-500 OT EQUATOR PINK CAP #500CN053-100 OT EQUATOR YELLOW CAP #100CN053-500 OT EQUATOR YELLOW CAP #500CN055-100 OT EQUATOR VIOLET CAP #100CN055-500 OT EQUATOR VIOLET CAP #500CN068-100 OT EQUATOR BLACK CAP FOR LAB #100CN068-500 OT EQUATOR BLACK CAP FOR LAB #500CN086-100 CLEAR CAP PLUS #100CN087-100 PINK CAP PLUS #100CN087-50 PINK CAP PLUS #50CN088-100 YELLOW CAP PLUS #100CN088-50 YELLOW CAP PLUS #50CN089-100 VIOLET CAP PLUS #100CN089-50 VIOLET CAP PLUS #50CN090-100 BLACK CAP PLUS #100CN090-50 BLACK CAP PLUS #50CN094-100 BLACK SMART BOX CAP FOR LAB. #100CN094-500 BLACK SMART BOX CAP FOR LAB. #500CN096-100 CLEAR CAP PLUS WITH PIN #100CN096-50 CLEAR CAP PLUS WITH PIN #50CN097-100 PINK CAP PLUS WITH PIN #100CN097-50 PINK CAP PLUS WITH PIN #50CN098-100 YELLOW CAP PLUS WITH PIN #100CN098-50 YELLOW CAP PLUS WITH PIN #50CN099-100 VIOLET CAP PLUS WITH PIN #100CN099-50 VIOLET CAP PLUS WITH PIN #50CT007-100 TITANIUM HOUSING PLUS #100DP-100 PROTECTIVE DISK #100DP-500 PROTECTIVE DISK #500DPR-100 PINK PROTECTIVE DISK #100DPR-50 PINK PROTECTIVE DISK #50ODSCAK-C ODSecure Cap Assort.KitODSHCPM-C ODSecure Housing CapsOT CAP; OT STRATEGY; OT REVERSE 3; OT EQUATOR PROFILE; SINGLE SPHERE AND ACCESSORIESSBE-100 SMART BOX OT EQUATOR #100SBE-50 SMART BOX OT EQUATOR #50SBE-500 SMART BOX OT EQUATOR #500Z-EQ-100PD PROTECTIVE DISK pcs.10Z-EQ-140CEG OT EQUATOR YELLOW RETENTIVE CAPS 4U.Z-EQ-140CEN OT EQUATOR BLACK RETENTIVE CAPS 4U.Z-EQ-140CER OT EQUATOR PINK RETENTIVE CAPS 4U.Z-EQ-140CET OT EQUATOR CLEAR RETENTIVE CAPS 4U.Z-EQ-140CEV OT EQUATOR VIOLET RETENTIVE CAPS 4U.Z-EQ-RC6 RETENTIVE CAP 6 pieces KIT EQZ-ILZ-RC5 RETENTIVE CAP 5 pieces Kit ILZ027CRGUS OT BAR YELLOW CLIP MEDIUM 1.8KG #6039SFE2 OT EQUATOR THREADED M2039SFM2 THREADED SPHERE M2 OT CAP MICRO039SFN2 SFERA SING. FIL. in TIT.040CRM CLEAR CAP MICRO #6040CRM-IQ Caps Micro, Clear (4 Pack)040CRMDR8 AQUA CAP DR8 MICRO ø 1.6 #6040CRMSN PINK CAP MICRO #6040CRMSN-IQ PINK CAP MICRO (4 Pack)040CRMSN-SM CAPPETTA ROSA MICRO 6 PZ040CRN CLEAR CAP NORMO #6040CRN-IQ Caps Standard, Clear (4 Pack)040CRNDR8 AQUA CAP DR8 NORMO ø 2.2 #6040CRNDR8-IQ AQUA CAP DR8 NORMO ø 2.2 (4 Pack)040CRNSN PINK CAP NORMO #6040CRNSN-IQ Caps Standard Soft, Pink (4 Pack)040CRNSN-SM CAPPETTA DIAM 2.50, ROSA040CRNSNDR8 PINK CAP DR8 NORMO ø 2.2 #6040CRNSNDR8-SM CAPPETTA DIAM 2.25, DR8 ROSA040TCM TITAN CAP MICRO #2041CAM OT CAP INOX BOX MICRO #2041CAM-SM CONTENITORE ACCIAIO MICRO, 2 PZ041CAN BOX INOX NORMO #2041CAN-SM CONTENITORE ACCIAIO NORMO, 2 PZ042AMN MONO OT BOX NORMO #2043CLM BLACK CAP MICRO FOR LAB #6043CLN BLACK CAP NORMO FOR LAB #6043CLN-IQ Caps Standard Lab. Use, Black (4 Pack)045ACS ASSORTED CAPS FOR BOX OT STRATEGY #12045CLS BLACK CAP OT STRATEGY FOR BOX #4045CSM CLEAR CAP OT STRATEGY FOR BOX #4045CSMAY YELLOW CAP OT STRATEGY FOR BOX #4045CSMDR8 AQUA OT STRATEGY DR8 CAP FOR BOX #4045CSMSN PINK CAP OT STRATEGY FOR BOX #4046CSM OT STRATEGY INOX BOX #2047ACS ASSORTED CAPS DUPL. OT STRATEGY #12047CLS BLACK CAP OT STRATEGY DUPLICABLE #4047CSD WHITE CAP OT STRATEGY DUPLICABLE #4047CSDAY YELLOW CAP OT STRATEGY DUPLICABLE #4047CSDSN PINK CAP OT STRATEGY DUPLICABLE #4048CAM SILVER CAP MICRO EXTRA-RESILIENT #6048COM GOLD CAP MICRO EXTRA-RESILIENT #6048CON GOLD CAP NORMO EXTRA-RESILIENT #6048CON-IQ GOLD CAP NORMO EXTRA-RESILIENT (4 Pack)049PCM GREEN CAP MICRO #6049PCMDR8 ORANGE CAP DR8 MICRO ø 1.6 #6049PCMDR8-SM CAPPETTA DR8 ARANCIO MICRO, 6 PZ049PCN GREEN CAP NORMO #6049PCNDR8 ORANGE CAP DR8 NORMO ø 2.2 #6060CRMAY YELLOW CAP MICRO #6060CRNAY YELLOW CAP NORMO #6060CRNAY-IQ Caps Standard X-Soft, Yellow (4 Pack)060CRNAYDR8 YELLOW CAP DR8 NORMO ø 2.2 #6064ACM ASSORTED CAPS MICRO OT CAP #24064ACN ASSORTED CAPS NORMO #24074KAM ASSORTED CAPS MICRO #54087CRS18 MICRO CONCAVE REPAIR SPHERE SET087CRS25 NORMO CONCAVE REPAIR SPHERE SET089SRS RECONSTRUCTIVE SPHERE SET092CAM SET OT CAP MICRO092ECQ CASTABLE OT EQUATOR W. CAPS & HOUSING093CTM SET OT CAP TECNO MICRO098CALUS SET OT STRATEGY FOR BOX INOX-US098SSSUS OT STRATEGY x DUPLICATION x USA099BSM OT CAP-OT BOX MONO MICRO100PD PROTECTIVE DISK #10100PD-IQ Protective Disc for 2.5mm Equator/2.5mm100PDR PINK PROTECTIVE DISK #10100PDY DISCHETTI PROTETTIVI pz.10139KSFM SET THREADED SPHERES M1.6 OT CAP MICRO139KSFN SET THREADED SPHERES M1.6 OT CAP NORMO140CAEY CONTENITORI ACC. EQUATOR pz.2140CEADR8 OT EQUATOR CAP ORANGE INT. ø 2,2MM 4u.140CEADR8-IQ ORANGE OT EQUATOR DR8 CAP ø 2.2 (4 Pack)140CEDR8 OT EQUATOR CAP AQUA C. INT. ø 2,2MM 4u.140CEDR8-IQ AQUA OT EQUATOR DR8 CAP ø 2.2 (4 Pack) | 2013 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | CUFF HEIGHT MEASURER | 2013 |
| Preformed AnchorEJX · Class 1 | — | Maker | KEF4MAEF 4 EASY FIX T-BASE h6KEF4MEF 4 EASY FIX T-BASE h4KEF4MLEF 4 EASY FIX T-BASE h9KMASRF KIT EASY FIX T-BASE h.6KMLSRF KIT EASY FIX T-BASE h9RMLEF TITANIUM EASY FIX T-BASE h9240GCLEF CASTABLE SLEEVE EASY FIX h9 | 1995 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | PIVOT FLEX PIVOT BLOCK; OT REVERSE 3036PTN10 TITANIUM PIVOT NORMO h10 #5036PTN9 TITANIUM PIVOT NORMO h9 #5333PEK7 SET PIVOT + CAP OT EQUATOR h7333PEK9 SET PIVOT + CAP OT EQUATOR h9336PTE7 PIVOT TITANIUM OT EQUATOR h7336PTE9 PIVOT TITANIUM OT EQUATOR h9 | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AAE-50 LABORATORY ANALOGS 50 u.ATEBH-500 ODSECURE ANALOG #500ATP-50 ANALOGUE PLUS CAP 50 pcs.BC038-100 OT EQUATOR CASTABLE SPHERE #100CAIN-10 OT EQUATOR-OT CAP IMPRESSION COPING #10CAIN-50 OT EQUATOR-OT CAP IMPRESSION COPING #50CAIN-500 OT EQUAT.-OT CAP IMPRESSION COPING #500CAIP-50 OT PLUS IMPRESSION COPING #50ICEB-US-BH-50 OT EQUATOR CAP EXTRACTOR-INSERTER #50VSL1 Scan Ladder Titanium screw #1 65 moreVSL8 Scan Ladder Titanium screw #8Z-EQ-ICT IMPRESSION COPING TRANSFER EQZ-EQ-LA LAB ANALOGUE EQZ-I-KIT-EQ Insertion-Extraction tool Set EQZ-ILZ-HC HEALING CAP TEMP ILZZ-ILZ-ICT IMPRESSION COPING TRANSFER ILZZ-ILZ-LA LAB ANALOGUE ILZ008MBG-IQ GINGIVA HEIGHT MEASURER008MDS SPHERE MEASURER008MDS-IQ SPHERE MEASURER010PSP18 PIVOT CASTABLE NORMO GREEN h10 #20044CAIM-IQ OT CAP IMPRESSION COPING MICRO ø 1.8 #4044CAIN-DIO IMPRESSION COPING 2 units044CAIN-IQ Impression coping (4 Pack)044CAINY TRANSFER da IMPRONTA NORMO pz.044CAIP-IQ EASY-LOCK IMPRESSION TRANSFER 4 PK044PPM-IQ ANALOG OT CAP MICRO (4 Pack)054PLS OT STRATEGY LONG CASTABLE PATRIX #4055SCM CASTABLE SPHERES MICRO #4055SCN CASTABLE SPHERES NORMO #4080RCN-IQ NORMO REAMER CAP082ATN-IQ NORMAL RETENTION TESTER CP085IAC-US CAPS INSERTION TOOL W. UDI124IMR-US REVERSE 3 INSERTION TOOL W. UDI144AE-DIO LABORATORY ANALOGS 2 units144AE-IQ EQUATOR LABORATORY ANALOG (4 Pack)144AEY ANALOGO ACC. da laboratorio EQ144ATP-IQ EASY-LOCK ANALOG 4 PK151SS CASTABLE OT EQUATOR 2u.154PCS OT STRATEGY CASTABLE SHORT PATRIX #4185SIS-US SEEGER METAL INSERTION TOOL W. UDI339SSE SPAZIATORE PER GUAINA429IOBM-US OT BAR EXTR./INSERTION TOOL W. UDI472ICV-US OT VERTICAL EXTR./INSERTION TOOL W. UDI485IC INSERTION/EXTRACTION TOOL FOR CAPS485IC-US CAPS EXTR./INSERTION TOOL W. UDI485IC-US-DIO MULTIUSE CAP INSERTER/EXTRACTOR TOOL485IC-US-IQ EQUATOR/OT CAPS INSERTER/EXTRACTOR TOOL485IC-US-SIS CAPS EXTR./INSERTION TOOL W. UDI485ICEY ESTRATTORE CAPP. c/st. INSERIT486ICS-US OT STRATEGY EXTR./INSERTION TOOL W. UDI488EIP PLUS CAP EXTRACTOR-INSERTER488EIP-US CAPS EXTR./INSERTION TOOL W. UDI488EIP-US-IQ CAPS EXTRACTOR/INSERTION TOOL W. UDI4896R INSERTION TOOL FOR CAPS491EC-US CAP EXTRACTOR TOOL W. UDI491SEIM EASY FIX T-BASE INSERTION TOOL760ACC-IQ RATCHET-SCREWDRIVER ADAPTER760CQC CONICAL SQUARE WRENCH FOR HANDPIECE h22760CQC-IQ CONICAL SQUARE WRENCH FOR HANDPIECE h22760CQCL-IQ CONICAL SQUARE WRENCH FOR HANDPIECE h32760CRD-US MANUAL TORQUE WRENCH W. UDI760CRD-US-DIO RATCHET TORQUE CONTROL DEVICE W. UDI760CRD-US-IQ RATCHET TORQUE CONTROL DEVICE W. UDI760CRD-US-SIS MANUAL TORQUE WRENCH W. UDI761ELEF LONG UNLOCKING TOOL h28.4761OTL OT LEVER774CHE CHIAVE QUADRATA774CHE-DIO OT EQUATOR SQUARE SCREW DRIVER + HOLDER774CQAET SQUARE DRIVER WITH HEX SHANK776CGC DYNAMOMETRIC SCREWDRIVER SWIVEL h21.5776CGC-IQ DYNAMOMETRIC SCREWDRIVER SWIVEL h21.5777CGL-IQ DYNAMOMETRIC SCREWDRIVER SWIVEL h26880CLR ADJUSTABLE OT LOCK SET983321 CHIAVE QUADRATA OT EQUATOR h10.5 | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Rhein'83 Srl as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Apr 2018 | K171409 | OT EQUATOR | NHA Endosseous Dental Implant Abutment |
| 11 Aug 2016 | K160382 | OT EQUATOR | NHA Endosseous Dental Implant Abutment |
| 25 Nov 2015 | K142211 | OT EQUATOR | NHA Endosseous Dental Implant Abutment |
| 21 Apr 2004 | K033630 | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (3).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RHEIN 83 SRLFDA reg. 9680939 | BOLOGNA Emilia-Romagna, Italy | Complaint file establishment, Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9012485). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.