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Sign in to claim this brandBISCO INC.
US
Last updated May 24, 2026
What BISCO INC. makes
Bisco Inc. manufactures dental materials and accessories for restorative procedures, including composite resins, bonding agents, and dental cements. Their portfolio includes trial pastes for temporary restorations, single-use application tools, and specialized mixing nozzles for precise material dispensing. The company also produces dental etching solutions, priming agents for prostheses, and resin-based modeling materials for dental applications.
Bisco Inc.’s products are regulated under the FDA’s UDI system, with devices classified as either Class I or Class II. These materials are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The company operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Bisco Inc. manufacture?
Bisco Inc. specializes in dental materials and accessories primarily used in restorative procedures. Their portfolio includes dental composite resins for fillings, bonding agents and sets for tooth preparation, dental etching solutions to prepare tooth surfaces, trial pastes for temporary restorations, and specialized tools like single-use application nozzles and cannulas for precise material dispensing. These products are designed to support procedures such as bonding, cementation, and prosthesis preparation in dental settings.
Where is Bisco Inc. based, and how does that affect its regulatory compliance?
Bisco Inc. is based in the United States, which means its devices are subject to U.S. regulatory requirements, including those managed by the FDA. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with U.S. traceability and identification standards. The FDA classifies these devices as either Class I or Class II, depending on their risk level and intended use, ensuring they meet applicable regulatory criteria for safety and effectiveness.
Which regulatory registries or databases list Bisco Inc.’s devices?
Bisco Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a standardized identifier to each device, enabling better tracking, traceability, and compliance monitoring in the U.S. market. This listing helps ensure transparency and regulatory oversight of the company’s dental materials and accessories.
How are Bisco Inc.’s devices classified under U.S. regulations?
Bisco Inc.’s devices are classified under the FDA’s medical device classification system as either Class I or Class II. Class I devices generally pose minimal risk and may require general controls for regulation, while Class II devices involve a higher level of risk and require special controls to ensure their safety and performance. The classification depends on factors like the device’s intended use, potential risks, and the procedures it supports in dental care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- bisco.com
- —
- —
- [email protected]
- Phone
- +1(847)534-6000
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 053529939
Catalogue (1223)
Page 23 of 25| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Barrier Gel 2-5g Syr w/Tips Pkg | G-96020P | FDA UDI | Class I | Unknown |
| Etch-37 w/BAC | E-5503EBM | FDA UDI | Class II | Unknown |
| Reveal HD Bulk | H-9332A2 | FDA UDI | Class II | Unknown |
| Aeliteflo LV | H-664A2F | FDA UDI | Class I | Unknown |
| Bisfil-II Cat 14g Cervical | A-1233P | FDA UDI | Class II | Unknown |
| Aelite Aesthetic Enamel | H-854A1 | FDA UDI | Class II | Active |
| Aelite All-Purpose Body | H-812A2 | FDA UDI | Class II | Active |
| Duo-Link Universal | A-19030P | FDA UDI | Class I | Active |
| Core-Flo DC Lite | AB-17410K | FDA UDI | Class II | Active |
| Choice 2 Try-In Paste | C-412A1 | FDA UDI | Class II | Active |
| Reveal HD Bulk | H-931A1 | FDA UDI | Class II | Unknown |
| CHOICE 2 Ven. Cement C2 Pkg | C-411C2P | FDA UDI | Class II | Unknown |
| Aelite Aesthetic Enamel | H-854D4P | FDA UDI | Class II | Unknown |
| Aelite Aesthetic Enamel | H-854B3 | FDA UDI | Class II | Unknown |
| Transluma ISO#100 Drill 1ea | X-81612 | FDA UDI | Class I | Unknown |
| Ortho Band Paste Blue 5g Pkg | F-6414P | FDA UDI | Class II | Unknown |
| Aelite Aesthetic Enamel | H-852A4 | FDA UDI | Class II | Unknown |
| Transluma ISO#120 Drill 2eaPkg | X-81623P | FDA UDI | Class I | Unknown |
| Mixing Pad 2-3/8x2-3/8 50/Pad | MXPD-002 | FDA UDI | Class I | Unknown |
| Aelite AesthEnamel D3 U/D Pkg | H-854D3P | FDA UDI | Class II | Unknown |
| Aelite Aesthetic Enamel | H-854B3 | FDA UDI | Class II | Unknown |
| Bulk Fill Composite Syringe Kit | H-93010K | FDA UDI | Class I | Active |
| Aeliteflo LV | H-664A2 | FDA UDI | Class II | Unknown |
| Porcelain Etchant | E-5707 | FDA UDI | Class II | Active |
| OrangeHandle Microbrush 25/pk | X-80251P | FDA UDI | Class I | Unknown |
| Etch-37 30ml Refill Pkg | E-56731P | FDA UDI | Class II | Unknown |
| eCement | C-5212 | FDA UDI | Class II | Active |
| Select HV Etch w/BAC | E-59160P | FDA UDI | Class II | Unknown |
| Pro-V C&B B1 50ml Syr. Refill Pkg | H-403B1P | FDA UDI | Class II | Unknown |
| Aelite AestheticEnamel C4 UD | H-854C4 | FDA UDI | Class II | Unknown |
| Z-Cem SA | D-47021P | FDA UDI | Class II | Unknown |
| BIS-CORE CAT 5gm Opaque Syr | A-1731 | FDA UDI | Class II | Unknown |
| All-Bond 3 | B-36010P | FDA UDI | Class II | Unknown |
| ORTHO-1 No Mix Primer 16gm Pkg | F-6102D | FDA UDI | Class II | Unknown |
| Transluma ISO#120 Drill 2ea | X-81623 | FDA UDI | Class I | Unknown |
| Aelite Aesthetic Enamel | H-854B1 | FDA UDI | Class II | Unknown |
| Fortify | K882915 | FDA 510(k) | Class II | Active |
| Biscem Translucent, Biscem Opaque | K060701 | FDA 510(k) | Class II | Active |
| Core-Flo D/C | K093470 | FDA 510(k) | Class II | Active |
| FluoroCal | K182917 | FDA 510(k) | Class II | Active |
| Illusion | K993192 | FDA 510(k) | Class II | Active |
| Bisco D/C Core Composite | K930405 | FDA 510(k) | Class II | Active |
| TheraCal DC | K143292 | FDA 510(k) | Class II | Active |
| All-Bond Universal w/BAC (not finalized) | K161051 | FDA 510(k) | Class II | Active |
| Bisco's Porcelain Veneer System | K861148 | FDA 510(k) | Class II | Active |
| Tescera Opaquer Powder/Sculpting Resin | K042804 | FDA 510(k) | Class II | Active |
| Sculpting Resin | K030585 | FDA 510(k) | Class II | Active |
| All-Bond 2 | K910860 | FDA 510(k) | Class II | Active |
| Tescera U-Bar And Barrels | K033472 | FDA 510(k) | Class II | Active |
| All-Bond Dentin Bonding System | K897020 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Bisco Inc. has two recall records, both initiated on 2008-04-28, with a status of terminated. The recalls pertain to BISCEM Self-Adhesive Luting Cement, where stability testing revealed that the product, when used in self-cure mode without light-curing, may exceed the specified setting time and exhibit reduced bond strength. The records do not indicate any additional reasons or variations in the recall scope.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 28, 2008 | Z-1696-2008 | — | terminated | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time. |
| Apr 28, 2008 | Z-1697-2008 | — | terminated | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strength. Bisco also determined that product component(s) may thicken slightly over time. |