FDA Registration
Active
🇺🇸 United States
3D DENTAL DESINGS AND DEVELOPMENT
Reg #: 3010864832
·
FEI: 3010862763
·
Expires 2026
Products
92
Proprietary Names
1
Establishment Types
2
Classifications
92
Registration Details
- Registration Name
- 3D DENTAL DESINGS AND DEVELOPMENT
- Registration Number
- 3010864832
- FEI Number
- 3010862763
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 16781 chagrin blvd, suite 434
- City
- Shaker Heights
- State
- OH
- ZIP
- 44120
- Country
- US
Regulatory Submissions
- 510(k) Number
- K000542
Owner / Operator
- Firm Name
- 3D Dental Designs and Development LLC
- Operator Number
- 10046685
- Address
- 16781 Chagrin Blvd Suite 434
- City
- Shaker Heights
- State
- OH
- Postal Code
- 44120
- Country
- US
- Correspondent
- Matt Goldstein
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2017-06-12 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2014-04-28 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2019-01-24 |
| Dress, Surgical | FYE | Class 1 | General, Plastic Surgery | No | 2017-01-17 |
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2017-11-30 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2021-07-15 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-11-20 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2015-11-20 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2015-11-20 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2015-11-20 |
| Dispenser, Liquid Medication | KYX | Class 1 | General Hospital | No | 2022-10-31 |
| Chair, Dental, Without Operative Unit | NRU | Class 1 | Dental | No | 2022-10-31 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2019-01-24 |
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2015-01-30 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-06-16 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2018-09-21 |
| Material, Impression | ELW | Class 2 | Dental | No | 2019-09-10 |
| Absorber, Saliva, Paper | KHR | Class 1 | Dental | No | 2022-10-31 |
| Floss, Dental | JES | Class 1 | Dental | No | 2023-01-19 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2022-10-31 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 2023-02-13 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2017-06-12 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2021-04-20 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2026-02-12 |
| Tester, Pulp | EAT | Class 2 | Dental | No | 2016-11-24 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 2026-03-12 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2016-07-13 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2016-07-05 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2019-09-10 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2014-05-12 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2020-09-08 |
| Point, Paper, Endodontic | EKN | Class 1 | Dental | No | 2016-07-03 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-07-08 |
| Knife, Margin Finishing, Operative | EJZ | Class 1 | Dental | No | 2018-07-03 |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | Class U | Unknown | No | 2016-08-18 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2018-06-25 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2023-01-19 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2018-09-05 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2023-03-23 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-03-02 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2021-03-02 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2021-03-02 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2019-01-24 |
| Oral Wound Dressing | OLR | Class U | Unknown | No | 2018-02-16 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2018-08-08 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2019-01-24 |
| Amalgamator, Dental, Ac-Powered | EFD | Class 1 | Dental | No | 2019-07-26 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2017-07-17 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2026-02-16 |
| Tube Impression And Matrix | KCQ | Class 1 | Dental | No | 2017-01-24 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2017-09-25 |
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2019-11-13 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2016-07-13 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 2026-02-16 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2022-10-31 |
| Apron, Protective | IWO | Class 1 | Radiology | No | 2022-02-10 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2019-09-10 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2017-02-07 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2016-06-16 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2019-09-10 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2022-10-31 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2017-03-30 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2017-03-30 |
| Needle, Dental | DZM | Class 1 | Dental | No | 2022-06-22 |
| Alloy, Amalgam | EJJ | Class 2 | Dental | No | 2017-07-05 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-08-31 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2017-01-23 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2016-09-15 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2026-02-12 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2020-09-21 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 2016-07-03 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2016-08-25 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2020-12-16 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2019-09-10 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2017-08-21 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2022-08-11 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2023-11-03 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2020-09-08 |
| Dispenser, Solid Medication | NXB | Class 1 | Physical Medicine | No | 2019-08-14 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2018-07-24 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2026-01-22 |
| Screen, Intensifying, Radiographic | EAM | Class 1 | Radiology | No | 2022-07-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2017-02-27 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2017-07-25 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2023-09-19 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 2022-07-19 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2022-10-31 |
| Cleanser, Root Canal | KJJ | Class U | Unknown | No | 2026-03-12 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2017-01-18 |
| Broach, Endodontic | EKW | Class 1 | Dental | No | 2023-02-20 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2017-06-12 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2026-02-12 |
Proprietary Names
JOY Smart Matrix Bands
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)