CLASS III Device recall · Reported 20 Feb 2013 · FDA Enforcement Report
Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor recalled
Ultradent Products is recalling Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, Impression Material, distributed nationwide in the US. The recall was initiated on 4 Feb 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0812-2013
- FDA event ID
- 64272
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Feb 2013
- FDA classified
- 13 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 4 Feb 2013 | Recall initiated by company | |
| 13 Feb 2013 | Classified by FDA | +9 days |
| 20 Feb 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect packaging of regular set and fast set cartridges.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Incorrect packaging of regular set and fast set cartridges.
Which lots are affected?
Lot No. B7DS3
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 64272This product is part of a recall event; the main page for the event is Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor recalled | Ultradent Products | Packaging Defects | Nationwide |
More recalls from Ultradent Products
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Jiffy Original Composite Polisher Cups (Coarse) recalled | Ultradent Products | Device Malfunction | 31 states |
| Device | CLASS II | Vit-l-escence Singles A3 recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Singles Universal Body (UB) Refill recalled | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Peak Universal Bond Self-Etch Bottle Kit, Part recalled | Ultradent Products | Other | Nationwide |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |