Manufacturer registered with FDA

Riellens Industria e Comercio Ltda

Lakewood Ranch, FL, United States. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10094040Manufacturer
Device types listed
1
Brands and models
200
510(k) clearances
0as applicant
Markets registered in
29 registrations outside the US
Establishments
1Brazil

Registered in 2 markets

Where regulators' registries name Riellens Industria e Comercio Ltda as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedBrazil: 9 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRiellens Industria e Comercio Ltda1 device types—Below
BrazilANVISAManufacturerRIELLENS INDUSTRIA E COMERCIO LTDA92011–2022Pure 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 Riellens Industria e Comercio Ltda currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
CMN Abutment Closed Tray Transfer - TMFPH-CMNCMN Abutment Open Tray Transfer - TMAPH-CMNCMN Closed Tray Transfer - TMFH-CMNCMN Digital Analogue - AD-CMNCMN Digital Hybrid Abutment Analogue - APRH-CMNCMN Digital Transfer - TDIH-CMNCMN Implant Analogue - A-CMNCMN Open Tray Transfer - TMAH-CMNCMN Titanium Abutment Analogue - AP-CMNCMN Universal Abutment Analogue - 3.3 by 4 mm - APU334-CMN
190 more
CMN Universal Abutment Analogue - 3.3 by 6 mm - APU336-CMNCMN Universal Abutment Analogue - 4.5 by 4 mm - APU454-CMNCMN Universal Abutment Analogue - 4.5 by 6 mm - APU456-CMNCMN Universal Abutment Transfer - 3.3 by 4 mm - TPU334-CMNCMN Universal Abutment Transfer - 3.3 by 6 mm - TPU336-CMNCMN Universal Abutment Transfer - 4.5 by 4 mm - TPU454-CMNCMN Universal Abutment Transfer - 4.5 by 6 mm - TPU456-CMNContra-Angle Hex Driver 0.9 mm – Long - CCAH09LContra-Angle Hex Driver 0.9 mm – Medium - CCAH09MContra-Angle Hex Driver 0.9 mm – Short - CCAH09CContra-Angle Hex Driver 1.2 mm – Long - CCAH12LContra-Angle Hex Driver 1.2 mm – Medium - CCAH12MContra-Angle Hex Driver 1.2 mm – Short - CCAH12CContra-Angle Mini Conical Abutment Insertion Driver - CCAIMPCContra-Angle Square Driver – Long - CCAQLContra-Angle Square Driver – Medium - CCAQMContra-Angle Square Driver – Short - CCAQCContra-Angle Unigrip Driver – Long - CCAULContra-Angle Unigrip Driver – Medium - CCAUMContra-Angle Unigrip Driver – Short - CCAUCDigital Hex Driver – Extra Long - CDHELDigital Hex Driver 0.9 mm – Long - CDH09LDigital Hex Driver 0.9 mm – Medium - CDH09MDigital Hex Driver 0.9 mm – Short - CDH09CDigital Hex Driver 1.2 mm – Long - CDH12LDigital Hex Driver 1.2 mm – Medium - CDH12MDigital Hex Driver 1.2 mm – Short - CDH12CDigital Mini Conical Abutment Hex Driver – 2 mm - CDMPCH20Digital Mini Conical Abutment Hex Driver – 2.5 mm - CDMPCH25Digital Square Driver – Long - CDQLDigital Square Driver – Medium - CDQMDigital Square Driver – Short - CDQCDigital Unigrip Driver – Long - CDULDigital Unigrip Driver – Medium - CDUMDigital Unigrip Driver – Short - CDUCES Estheticone Analogue – RP Anti-Rotational - ARPA-ESES Estheticone Analogue – RP Rotational - ARPR-ESES Stainless Steel Closed Tray Transfer – RP Anti-Rotational - TRPMFAH-ESES Stainless Steel Closed Tray Transfer – RP Rotational - TRPMFRH-ESES Stainless Steel Open Tray Transfer – RP Anti-Rotational - TRPMAAH-ESES Stainless Steel Open Tray Transfer – RP Rotational - TRPMARH-ESGMN Abutment Analog - AP-GMNGMN Abutment Closed Tray Transfer - TMFPU-GMNGMN Abutment Open Tray Transfer - TMAPU-GMNGMN Contra-Angle Unigrip Driver – Long - CCAUL-GMNGMN Contra-Angle Unigrip Driver – Medium - CCAUM-GMNGMN Contra-Angle Unigrip Driver – Short - CCAUC-GMNGMN Digital Hybrid Abutment Analogue - AHPD-GMNGMN Digital Implant Transfer - TDIU-GMNGMN Digital Unigrip Driver – Long - CDUL-GMNGMN Digital Unigrip Driver – Medium - CDUM-GMNGMN Digital Unigrip Driver – Short - CDUC-GMNGMN Hybrid Abutment Analogue - AH-GMNGMN Implant Closed Tray Transfer - TMFU-GMNGMN Implant Open Tray Transfer - TMAU-GMNGMN Titanium Implant Analogue - A-GMNGMN Unigrip Torque Wrench Driver – Long - CTUL-GMNGMN Unigrip Torque Wrench Driver – Medium - CTUM-GMNGMN Unigrip Torque Wrench Driver – Short - CTUC-GMNHE B Closed Tray Transfer – NP - TNPMFH-BHE B Closed Tray Transfer – RP - TRPMFH-BHE B Closed Tray Transfer – WP - TWPMFH-BHE B Digital Analogue – RP - ADRP-BHE B Digital Transfer – RP - TDRPIH-BHE B Open Tray Transfer – NP - TNPMAH-BHE B Open Tray Transfer – RP - TRPMAH-BHE B Open Tray Transfer – WP - TWPMAH-BHE B Stainless Steel Analogue – NP - ANP-BHE B Stainless Steel Analogue – RP - ARP-BHE B Stainless Steel Analogue – WP - AWP-BHexagonal Torque Wrench Driver 0.9 mm – Long - CTH09LHexagonal Torque Wrench Driver 0.9 mm – Medium - CTH09MHexagonal Torque Wrench Driver 0.9 mm – Short - CTH09CHexagonal Torque Wrench Driver 1.2 mm – Long - CTH12LHexagonal Torque Wrench Driver 1.2 mm – Medium - CTH12MHexagonal Torque Wrench Driver 1.2 mm – Short - CTH12CHI CE Stainless Steel Analogue – NP - ANP-CEHI CE Stainless Steel Analogue – RP - ARP-CEHI CE Stainless Steel Analogue – WP - AWP-CEM.U Closed Tray Transfer with Screw – RP (Model 2) - TRPMF2-MUM.U Conical Mini Abutment Digital Transfer - TDMPCH-MUM.U Digital Analogue – AD-MUM.U Rotational Analogue – RP - ARP-MUM.U Rotational Analogue – WP - AWP-MUM.U Rotational Closed Tray Transfer – RP - TRPMFR-MUM.U Rotational Closed Tray Transfer – WP - TWPMFR-MUM.U Rotational Open Tray Transfer – RP - TRPMARH-MUM.U Rotational Open Tray Transfer – WP - TWPMARH-UMMini Conical Abutment Hex Torque Wrench Driver – 2 mm - CTMPCH20Mini Conical Abutment Hex Torque Wrench Driver – 2.5 mm - CTMPCH25MP Micro Abutment Digital Analogue - ADMP-MPMP Micro Abutment Digital Transfer - TDMP-MPMS C1 Closed Tray Transfer – NP - TNPMF-C1MSMS C1 Closed Tray Transfer – RP - TRPMF-C1MSMS C1 Implant Analogue – NP - ANPC1MS C1 Implant Analogue – RP - ARPC1-MSMS C1 Implant Analogue – WP - AWPC1-MSMS Closed Tray Transfer – 3.3 mm - T33MFH-MSMS Closed Tray Transfer – 3.75 mm - T375MFH-MSMS Implant Analogue – 3.3 mm - A33-MSMS Implant Analogue – 3.75 mm - A75-MSMS Open Tray Transfer – 3.3 mm - T33MAH-MSMS Open Tray Transfer – 3.75 mm - T375MAH-MSNA Closed Tray Transfer – NP - TNPMFU-NANA Closed Tray Transfer – RP - TRPMFU-MANA Digital Analogue – NP - ADNP-NANA Digital Analogue – RP - ADRP-NANA Digital Transfer – NP - TDNPU-NANA Digital Transfer – RP - TDRPU-NANA Implant Analogue – 3 mm - A30-NANA Implant Analogue – NP - ANP-NANA Implant Analogue – RP - ARP-NANA Open Tray Transfer – 3 mm - T30MAU-NANA Open Tray Transfer – NP - TNPMAU-NANA Open Tray Transfer – RP - TRPMAU-NANEO Micro Abutment Analogue – Anti-Rotational - AMPA-NEONEO Micro Abutment Analogue – Rotational - AMPR-NEONEO Micro Abutment Closed Tray Transfer – Anti-Rotational - TMPMFAU-NEONEO Micro Abutment Closed Tray Transfer – Rotational - TMPMFRU-NEONEO Micro Abutment Open Tray Transfer – Anti-Rotational - TMPMAAU-NEONEO Micro Abutment Open Tray Transfer – Rotational - TMPMARU-NEOProsthetic Key - KPRRS Titanium Analogue – 6 - A60-RSRS Titanium Analogue – NP - ANP-RSRS Titanium Analogue – RP - ARP-RSRS Titanium Analogue – WP - AWP-RSRS Titanium Closed Tray Transfer – NP - TNPMFH-RSRS Titanium Closed Tray Transfer – RP - TRPMFH-RSRS Titanium Closed Tray Transfer – WP - TWPMFH-RSRS Titanium Open Tray Transfer – 6 - T60MAH-RSRS Titanium Open Tray Transfer – NP - TNPMAH-RSRS Titanium Open Tray Transfer – RP - TRPMAH-RSRS Titanium Open Tray Transfer – WP - TWPMAH-RSSI Abutment Analogue – RN - ARNP-SISI Abutment Analogue – WN - AWNP-SISI Abutment Closed Tray Transfer – RN - TRNMFU-SISI Abutment Closed Tray Transfer – WN - TWNMFU-SISI Abutment Open Tray Transfer – RN - TRNMAU-SISquare Adapter for Torque Wrench - AQCTSquare Torque Wrench Driver – Long - CTQL
2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
RIELLENS INDUSTRIA E COMERCIO LTDAFDA reg. 3017508379Vargem Grande Paulista Sao Paulo, BrazilManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094040). 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.