FDA Registration Active 🇧🇷 Brazil

ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT.

Reg #: 3013641573 · FEI: 3013641573 · Expires 2026
Products
17
Proprietary Names
71
Establishment Types
2
Classifications
17

Registration Details

Registration Name
ORTHOMETRIC IND. E COM. DE PROD. MED. ODONT.
Registration Number
3013641573
FEI Number
3013641573
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rua Irineu Martins, 280
City
Marilia Sao Paulo
Country
BR

Regulatory Submissions

510(k) Number
K131042

Owner / Operator

Firm Name
Orthometric Ind. e Com. de Prod. Med. Odont.
Operator Number
10056882
Address
Rua Irineu Martins, 280
City
Marília
State
Sao Paulo
Postal Code
17539059
Country
BR
Correspondent
Orthometric Industria e Comercio LTDA

US Agent

Business Name
BHP CONSULTING LLC
Contact Name
Bruno Souza
Address
1207 Delaware Ave # 1939
City
Wilmington
State
DE
ZIP
19806
Country
US
Phone
301 4448132

Products

Device Name Product Code
Band, Material, Orthodontic DYO
Bur, Dental EJL
Bracket, Metal, Orthodontic EJF
Activator, Ultraviolet, For Polymerization EBZ
Band, Elastic, Orthodontic ECI
Wire, Orthodontic DZC
Paper, Articulation EFH
Spring, Orthodontic ECO
Retainer, Screw Expansion, Orthodontic DYJ
Tube, Orthodontic DZD
Pusher, Band, Orthodontic ECS
Plier, Orthodontic JEX
Instruments, Dental Hand DZN
Clamp, Wire, Orthodontic ECN
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
Positioner, Tooth, Preformed KMY
Bracket, Ceramic, Orthodontic NJM

Proprietary Names

ORTHOMETRIC BANDS ORTHOMETRIC BUR U-CLIP BRACKETS PREMIUM ELITE BRACKETS PREMIUM SERIES BRACKETS ULTRA-P BRACKETS ADVANCED SERIES BRACKETS LINEA D2 BRACKETS ORTHOMETRIC SMS BRACKETS BIOVERSATIL BRACKETS CAPELOZZA BRACKETS LEDX-PRO ORTHOMETRIC ELASTOMERICS - INTRA ORAL ORTHOMETRIC ELASTOMERICS - SEPARATOR ORTHOMETRIC ELASTOMERICS - EXTRA ORAL ORTHOMETRIC ELASTOMERICS - PACKING FOR PATIENT ORTHOMETRIC ELASTOMERICS - CHAIN ORTHOMETRIC ELASTOMERICS - ELASTIC POSITIONER ORTHOMETRIC ELASTOMERICS - MODULAR LIGATURE ORTHOMETRIC ELASTOMERICS - STICK LIGATURE SKY CHOICE PATIENT STICK TIES SKY CHOICE ELASTIC CHAIN ORTHOMETRIC ELASTOMERICS NON-LATEX ORTHOMETRIC ELASTOMERICS - BLACK LATEX ORTHOFLEXY ELASTOMERIC ORTHOMETRIC SS - CrNi - BRAIDED RHODIUM ORTHOMETRIC BETA FLEXY ORTHOMETRIC STRAIGHT WIRE BETA FLEXY FLEXY NiTi REVERSE CURVE ORTHOMETRIC SS - CrNi - BRAIDED SS ORTHOMETRIC ARCHWIRES KIT FLEXY NiTi THERMO ACTIVE ORTHOMETRIC SS - CrNi ORTHOMETRIC SS - CrNi - STRAIGHT WIRE ORTHOMETRIC RHODIUM ARCHWIRES SEQUENCE ORTHOMETRIC COLBOLOY - CrCo FLEXY NiTi - ARCHWIRES KIT FLEXY NiTi SUPER ELASTIC RHODIUM LINEA ARCHWIRES FLEXY NiTi COPPER RHODIUM FLEXY NiTi SUPER ELASTIC BIOVERSATIL ARCHWIRES ORTHOMETRIC SS CrNi RHODIUM ORTHOMETRIC SS - CrNi - WIRE FOR LIGATURE FLEXY NiTi COPPER - CuNiTi ORTHOMETRIC ACETATE TRACING PAPER FLEXY NITI DISTALIZING OPEN SPRING FLEXY NITI CLOSED SPRING FLEXY NITI OPEN SPRING ICERAM CLEAR DISTALIZER BIOVERSATIL TUBES LINEA TUBES ADVANCED SERIES TUBES PREMIUM SERIES TUBES ICERAM MINI TUBES CAPELOZZA TUBES MJANSON TUBES NANO TUBES ORTHOCHEWIE ORTHOMETRIC PLIER ORTHOMETRIC INSTRUMENTAL LINEA STOP ORTHOMETRIC LINGUAL BUTTON ORTHOMETRIC STOP STRAIGHT BALL POINT HOOKS ICERAM BUTTON SCANNER INTRAORAL IOS - DENTALINK ORTHOMETRIC PRO ALIGNER X ICERAM ICERAM-P ICE CLEAR

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device