FDA Registration
Active
🇺🇸 United States
TP ORTHODONTICS, INC.
Reg #: 1815540
·
FEI: 1815540
·
Expires 2026
Products
27
Proprietary Names
129
Establishment Types
2
Classifications
27
Registration Details
- Registration Name
- TP ORTHODONTICS, INC.
- Registration Number
- 1815540
- FEI Number
- 1815540
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 CENTER PLAZA
- City
- LA PORTE
- State
- IN
- ZIP
- 46350
- Country
- US
Regulatory Submissions
- 510(k) Number
- K780619
Owner / Operator
- Firm Name
- TP ORTHODONTICS, INC.
- Operator Number
- 1815540
- Address
- 100 CENTER PLAZA, --
- City
- La Porte
- State
- IN
- Postal Code
- 46350
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2021-03-04 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2006-01-06 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2008-12-08 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2021-11-17 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2006-01-06 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2006-01-06 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2021-11-17 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2006-01-06 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2006-01-06 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2006-01-06 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2014-04-28 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2006-01-06 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2006-01-06 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2022-12-05 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2022-12-05 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2006-01-06 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2011-12-14 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2006-01-06 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2021-03-04 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2020-07-01 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2021-03-04 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2019-08-14 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2006-01-06 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2006-01-06 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 2006-01-06 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2006-01-06 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2021-11-17 |
Proprietary Names
Bite Stick
Orthodontic instruments
Swivel Key
Heat Activated Nickel-Titanuim Preformed Archwire
TP Original Wire
Aesthetic Nickel-Titanuim Preformed Archwire
Multi-Strand Preformed Archwire
Nickel-Titanuim Preformed Archwire
Pre-torqued Preformed Archwire
Looped Preformed Archwire
Stainless Steel Preformed Archwire
Lip Bumper
TiMolium Preformed Archwire
Bio-Arch Wires
Aesthetic Stainless Steel Preformed Archwire
Ligature Wire on Spool
Preformed Ligature Ties
Lip Bumper Coated
Lip Bumper with Pads
Stainless Steel Straight Archwire
VELA Archwire System
Bow-Flex Archwire
Miscellaneous Wires
Pre-Finisher
Pre-finisher appliance with seating spring
Custom tooth positioner
Custom retainer
Disposable Dispensing Tips
Norm-O Impression Trays
Solay Disposable impression Trays
Extend-O Iimpression Trays
Tip-Edge Plus NX
Tip-Edge Rx-I
Begg Metal Bracket
Nu-Edge, Straight Edge, Tip Edge, Advant- Edge, Twin-Edge Bracket
256 Begg Bracket
Nu-Edge NX
Nu-Edge SL Pre-coated Metal bracket
Nu-Edge SL Metal Bracket
Tip-Edge Plus Metal
Nu-Edge II Cobalt Chromium Twin bracket
Refine
ROTATING SPRINGS
VektorPRO Appliance-Spring
SPRING PINS
COIL SPRINGS
SEPARATING SPRINGS
Torquing auxiliaries
Lock Pins Oriented
UPRIGHTING SPRINGS
ORTHODONTIC SPRINGS
Lock Pins
Twin Tip-Edge Aux.
EDGEWISE BRACKETS
256 BRACKETS
PRE-FIT PREFORMED BANDS
Molar Band Assemblies
Molar Band
Straight shooter Ligature Applicator
Elastomeric Seperators
Tru-Force
Bump-R-Sleeve tubing
Zing String
E-Chain
Sep-A-Rings
Super Slick
Elastomeric Ligature ties
Elastomeric tubing
Mini Stix
TPO Elastic thread
E-Links
Elastomeric thread
TPO Latex Elastics
Elastomeric ligature ties
Elastics
WAX STRIPS
WAFERS
ORTHODONTIC PLIERS
Enamel Conditioner
Click-It Self Ligating Bracket
SEPARATION MAINTAINERS
CRIMPABLE HOOK
Lingual Hook attachments
Lingual Button attachments
Lingual Cleat attachments
RETAINING RINGS
Bi level Pin
MXI CERAMIC POWER PINS
Power Pin
CRIMPABLE STOPS
RUMELY TRACTION HOOK
Aesthetic crimpable stop
ELASTIC OUTRIGGER
Power hooks
Aesthetic crimpable hook
TRACT HK W/LIGATING CHAIN
Debonding burs
Labial Trauma splint
Bondable Lingual Retainer
Lingual Bond-a-Splint Retainer
Hawley Retainer
Perio Bond-a-Bar
Baurmash bondable Arch Bar
Flip-Lock Herbst Appliance
Accufit retainer
Lip and Cheek Retractor
Bonding accessories
MESIO-DISTAL REDUCER
ClearVu
MXI
InVu
Plus Ceramic
Tip Edge PLUS with pre-applied adhesive
InVu with pre-applied adhesive
ClearVu with pre-applied adhesive
TONGUE-AWAY
BUCCAL TUBES
Cobalt Chromium Tubes
Cast Begg Molar Tubes
Bondable Molar tubes
Weldable Molar tubes
Cast Tip-Edge Molar Tubes
Seamless Standard Tube
Misc. Tubes & Attachments
Seamless Begg Tubes
Seamless Tip-Edge Tubes
Foam Pellets
Disposable brushes
Disposable Spatulas
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device