Manufacturer registered with FDA
Sharp Detail Orthodontic Laboratory
La Mesa, CA, United States. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Mexico
Devices listed with FDA
What Sharp Detail Orthodontic Laboratory currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | RETAINER, SCREW EXPANSION, ORTHODONTIC | 2017 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | MAINTAINER, SPACE PREFORMED, ORTHODONTIC | 2017 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | WIRE, ORTHODONTIC | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | TUBE, ORTHODONTIC | 2018 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Band, elastic, orthodontic | 2018 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | BAND, PREFORMED, ORTHODONTIC | 2017 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | WAX, DENTAL, INTRAORAL | 2017 |
| Preformed ClaspEHP · Class 1 | — | Maker | CLASP, PREFORMED | 2017 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | BRACKET, METAL, ORTHODONTIC | 2018 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | POSITIONER, TOOTH, PREFORMED | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Sharp Detail Orthodontic Laboratory S DE EL DE CVFDA reg. 3014425175 | Tijuana Baja California, Mexico | Manufacturer |
Other names on FDA records
Sharp Detail Orthodontic Laboratory S DE EL DE CV
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055967). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.