Manufacturer registered with FDA
Concise Enterprises
Sialkot, Pakistan. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 532 registrations outside the US
- Establishments
- 1Pakistan
Registered in 5 markets
Where regulators' registries name Concise Enterprises as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Concise Enterprises | 13 device types | — | Below |
| South Korea | MFDS | Manufacturer | CONCISE ENTERPRISES | 15 | 2010–2010 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Concise Enterprises | 8 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Concise Enterprises | 8 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CONCISE ENTERPRISES | 1 | 2014–2014 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Concise Enterprises currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Curette, Dental ForcepsDental Tweezers, Dental Scaler, Dental ExcavatorExamination Instruments, Restorative Instruments, Periodontal Instruments, Extraction Instruments | 2009 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable Mouth Mirror, Double-Sided Mouth Mirror, Rear Surface MirrorPlain Mouth Mirror, Front Surface Mirror, Concave Mouth Mirror | 2009 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Tray | 2009 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 2009 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Carver and Dental Amalgam | 2009 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Dental Instruments, EIY, Filling, Plastic | 2009 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HANDLE, INSTRUMENT, DENTAL | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | — | 2009 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | Excavator, Operative InstrumentsSpoon Excavator, Spoon Excavator (Half Hollenback), N-Excavator, Spoon Excavator (Right Angle) | 2009 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | CARVER, DENTAL AMALGAM, OPERATIVE | 2009 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BURNISHER, OPERATIVE | 2009 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 2009 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | SCALER, PERIODONTIC | 2009 |
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 |
|---|---|---|
| CONCISE ENTERPRISESFDA reg. 3003334541 | Sialkot Punjab, Pakistan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029712). 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.