Data / Medical devices / United States / New World Imports, Inc.
New World Imports, Inc.: FDA-registered device maker in Nashville, TN, United States, 2 510(k) clearances
New World Imports, Inc. is registered with the FDA (registration 1044117) in Nashville, TN, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 12, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1044117
- FEI number
- 1000112899
- Address
- 160 Athens Way, Nashville, TN, United States, 37228
- Owner or operator
- NEW WORLD IMPORTS, INC. (1044117)
- Roles
- Specification developer
- First device listed
- January 19, 1978
- Registered through
- 2026
- Brand names listed
- CareALL, Freshmint
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | 1 | Specification developer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Specification developer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 1996 | K963746 | IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID | JES | Substantially Equivalent | Whitehill Oral Technologies, Inc. | accessdata.fda.gov |
| November 30, 1994 | K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | KOO | Substantially Equivalent | Procter & Gamble Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Cleanser, Denture, Over The Counter
- All makers of Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
- All makers of Toothbrush, Manual
- All makers of Floss, Dental
Updated December 12, 1996. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.