Data / Medical devices / United States / Kulzer, LLC
Kulzer, LLC: FDA-registered device maker in South Bend, IN, United States, 3 510(k) clearances
Kulzer, LLC is registered with the FDA (registration 1821514) in South Bend, IN, United States. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 19, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1821514
- Address
- 4315 S. Lafayette Blvd., South Bend, IN, United States, 46614
- Owner or operator
- Kulzer, LLC (9056636)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- May 6, 1994
- Registered through
- 2026
- Brand names listed
- IVORY RUBBER DAM, IVORY RUBBER DAM CLAMP, IVORY RUBBER DAM FORCEPS, IVORY RUBBER DAM INTRO KIT, Ivory, Ivory Rubber Dam Complete Kit, Ivory Rubber Dam Frame, Ivory Rubber Dam Starter Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Rubber Dam | EEF | 1 | Contract manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rubber Dam Clamp | EJG | 1 | Contract manufacturer | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Contract manufacturer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Contract manufacturer, Manufacturer | 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 19, 2025 | K254063 | iCEM Universal Plus | EMA | Substantially Equivalent | Kulzer, LLC | accessdata.fda.gov |
| November 17, 1992 | K924024 | ORTHO WAX | EGD | Substantially Equivalent | Heraeus Kulzer, Inc. | accessdata.fda.gov |
| January 12, 1982 | K812805 | STEELE'S ECON. PINK BASEPL. WAXES, I-III | EGD | Substantially Equivalent | Modern Materials | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2014 | 68223 | Class II | Terminated | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or redu | The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irrita | accessdata.fda.gov |
| February 10, 2014 | 67475 | Class II | Terminated | BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also | As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is containe | accessdata.fda.gov |
| July 9, 2007 | 44827 | Not yet classified | Terminated | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. | The material may solidify in the bottle, and thus be rendered unusable. | accessdata.fda.gov |
| November 1, 2003 | 29993 | Not yet classified | Terminated | Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360); catalog number 66009585. | Packaging defects could result in improper mixing ratios and unusable impressions. | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Rubber Dam Clamp
- All makers of Wax, Dental, Intraoral
- All makers of Retractor, All Types
- All makers of Paper, Articulation
- All makers of Cement, Dental
- All makers of Frame, Rubber Dam
Updated December 19, 2025. 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.