Medical device manufacturer
Ultradent Products, Inc.
Ultradent Products, Inc. holds 104 FDA 510(k) clearances across 22 product codes. Median elapsed review time is 73 days. openFDA lists 20 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 104
- Product codes
- 22
- Median review
- 73 days
- Recall records
- 20
How does FDA spell Ultradent Products, Inc.?
FDA publishes this company under 4 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| Ultradent Products Inc. | device/registrationlisting | normalised |
| Ultradent Products, Inc. | device/recall | normalised |
| Ultradent Products, Inc. | device/510k | normalised |
| Ultradent Products, Inc. | device/enforcement | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Ultradent Products, Inc. file in?
22 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | 19 | 46 days | |
| EBF | Material, Tooth Shade, Resin | 17 | 70 days | |
| EMA | Cement, Dental | 9 | 55 days | |
| LBH | Varnish, Cavity | 9 | 70 days | |
| EBC | Sealant, Pit And Fissure, And Conditioner | 7 | 99 days | |
| EBZ | Activator, Ultraviolet, For Polymerization | 7 | 48 days | |
| EJK | Liner, Cavity, Calcium Hydroxide | 5 | 68 days | |
| KIF | Resin, Root Canal Filling | 5 | 35 days | |
| KJJ | Cleanser, Root Canal | 5 | 78 days | |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 4 | 82 days | |
| MVL | Cord, Retraction | 4 | 66 days | |
| DYW | Bracket, Plastic, Orthodontic | 3 | 17 days | |
| EFB | Handpiece, Air-Powered, Dental | 1 | 89 days | |
| EFS | Unit, Oral Irrigation | 1 | 73 days | |
| EIG | Retractor, All Types | 1 | 57 days | |
| EIH | Powder, Porcelain | 1 | 34 days | |
| EJI | Syringe, Cartridge | 1 | 100 days | |
| ELW | Material, Impression | 1 | 93 days | |
| JES | Floss, Dental | 1 | 74 days | |
| KOJ | Airbrush | 1 | 77 days | |
| LFC | Device, Caries Detection | 1 | 40 days | |
| LYC | Bone Grafting Material, Synthetic | 1 | 300 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Ultradent Products, Inc. had a recall?
openFDA lists 20 recall records naming this company across its whole history, of which 1 was opened in the last 12 months and is not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1689-2026Class IIOpen, ClassifiedEHJ
Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment.
Z-3066-2024Class IIOpen, ClassifiedEBF
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3067-2024Class IIOpen, ClassifiedEBF
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3068-2024Class IIOpen, ClassifiedEBF
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-1368-2022Class IICompletedKLE
SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact bond strength and restoration while using the primer.
Showing the 5 most recently initiated of 20.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Ultradent Products, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K262228 | Transcend Bulk Fill Flowable Composite | EBF | 1 | |
| K261404 | UltraEZ | LBH | 1 | |
| K240743 | Peak Universal Bond | KLE | 2 | |
| K240694 | FORMA Composite (Shade A3D) | EBF | 1 | |
| K221909 | J-Temp | EBF | 1 | |
| K220471 | VALO X, VALO X Accessory Lenses | EBZ | 4 | |
| K211905 | UltraCal XS | KIF | 114 | |
| K211237 | UltraTemp Rez II | EMA | 78 | |
| K210550 | VALO Grand Corded and Accessory Lenses | EBZ | 4 | |
| K190627 | VALO Grand Corded | EBZ | 48 |
Source: openFDA device/510k · retrieved
Where is Ultradent Products, Inc. registered?
FDA lists 1 registered establishment for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Ultradent Products, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.