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
- [email protected]
- Phone
- 301 4448132
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2018-06-04 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2022-03-17 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2018-01-26 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2023-01-20 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2018-01-26 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2018-01-26 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 2022-03-21 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2022-03-17 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2023-05-17 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2018-01-26 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2023-05-17 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2018-07-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2022-04-11 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2022-04-11 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2023-11-02 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2022-05-05 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2023-05-09 |
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