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Sign in to claim this brandLANCER ORTHODONTICS, INC.
US
Last updated May 23, 2026
What LANCER ORTHODONTICS, INC. makes
The company produces metal orthodontic brackets, including the Intrigue series, for use in braces, as well as extraoral headgear like the Lancer Gear for correcting jaw alignment. It also manufactures fatty acid-based dental cement, such as Rely-a-Bond, for bonding orthodontic appliances, and optical brackets like the Optyc for improved visibility.
All listed devices fall under FDA Class II regulation and are included in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for these orthodontic and dental products.
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 Lancer Orthodontics, Inc. manufacture?
Lancer Orthodontics, Inc. specializes in orthodontic devices, including metal orthodontic brackets like the Intrigue series, which are used in braces to align teeth. They also produce extraoral headgear, such as the Lancer Gear, designed to correct jaw alignment by applying external force. Additionally, the company manufactures fatty acid-based dental cement, such as Rely-a-Bond, which bonds orthodontic appliances to teeth, and optical brackets like the Optyc for enhanced visibility during treatment.
Where is Lancer Orthodontics, Inc. based, and how does this affect its devices?
Lancer Orthodontics, Inc. is based in the United States. Since it operates within the U.S., its devices must comply with U.S. regulatory requirements, including those set by the FDA. This includes classification under FDA’s regulatory framework, ensuring safety, effectiveness, and proper labeling for its orthodontic products like brackets, headgear, and dental cement.
Which regulatory registries list Lancer Orthodontics, Inc.’s devices?
Lancer Orthodontics, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices like orthodontic brackets (e.g., Intrigue), headgear (e.g., Lancer Gear), and dental cements (e.g., Rely-a-Bond) throughout their lifecycle, ensuring transparency and regulatory compliance.
How are Lancer Orthodontics, Inc.’s devices classified by the FDA?
All of Lancer Orthodontics, Inc.’s listed devices fall under FDA Class II regulation. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Examples include orthodontic brackets, headgear, and dental cements, which require validation of performance and labeling requirements to meet regulatory standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 045545589
Catalogue (408)
Page 8 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Intrigue | 230-222 | FDA UDI | Class II | Active |
| Intrigue | 246-211 | FDA UDI | Class II | Active |
| Velocity | 24M-12R | FDA UDI | Class II | Active |
| Velocity | 24M-68R0 | FDA UDI | Class II | Active |
| Lancer Gear | 830-014 | FDA UDI | Class II | Active |
| Intrigue | 230-061 | FDA UDI | Class II | Active |
| Intrigue | 246-112 | FDA UDI | Class II | Active |
| Velocity | 24M-32L | FDA UDI | Class II | Active |
| Intrigue | 231-421 | FDA UDI | Class II | Active |
| Intrigue | 230-131 | FDA UDI | Class II | Active |
| Intrigue | 230-212 | FDA UDI | Class II | Active |
| Intrigue | 230-161 | FDA UDI | Class II | Active |
| Intrigue | 230-051 | FDA UDI | Class II | Active |
| Optyc | 246-511 | FDA UDI | Class II | Active |
| Intrigue | 231-222 | FDA UDI | Class II | Active |
| Intrigue | 246-353 | FDA UDI | Class II | Active |
| Intrigue | 246-323 | FDA UDI | Class II | Active |
| Intrigue | 231-012 | FDA UDI | Class II | Active |
| Intrigue | 230-002 | FDA UDI | Class II | Active |
| Velocity | 24M-62R0 | FDA UDI | Class II | Active |
| Intrigue | 246-202 | FDA UDI | Class II | Active |
| Intrigue | 231-272 | FDA UDI | Class II | Active |
| Velocity | 24M-48N | FDA UDI | Class II | Active |
| Velocity | 24R-62L | FDA UDI | Class II | Active |
| Velocity | 24M-38R | FDA UDI | Class II | Active |
| Velocity | 24R-22L | FDA UDI | Class II | Active |
| Optyc | 246-512 | FDA UDI | Class II | Active |
| Fuji | D11-9662 | FDA UDI | Class II | Active |
| Ultra Band-Lok | 811-403 | FDA UDI | Class II | Active |
| Lancer Gear | 830-114 | FDA UDI | Class II | Active |
| Velocity | 24R-68L | FDA UDI | Class II | Active |
| Velocity | 24R-58U | FDA UDI | Class II | Active |
| Lancer Gear | 830-023 | FDA UDI | Class II | Active |
| Velocity | 24R-32R | FDA UDI | Class II | Active |
| Hi-Pull | 830-503 | FDA UDI | Class II | Active |
| Velocity | 24M-32R | FDA UDI | Class II | Active |
| Reliance | 811-013 | FDA UDI | Class II | Active |
| Lancer Gear | 830-025 | FDA UDI | Class II | Active |
| Equa-Pull | 830-032 | FDA UDI | Class II | Active |
| Lancer Gear | 830-125 | FDA UDI | Class II | Active |
| Velocity | 24R-12R | FDA UDI | Class II | Active |
| Velocity | 24R-18L | FDA UDI | Class II | Active |
| Fuji | D11-9005 | FDA UDI | Class II | Active |
| Hi-Pull | 830-312 | FDA UDI | Class II | Active |
| Titanal, Sterling Spring, Dual Flex, Memorex, Bendallo | K904091 | FDA 510(k) | Class I | Active |
| Blugoo Hd | K071192 | FDA 510(k) | Class II | Active |
| Perma Mesh | K904089 | FDA 510(k) | Class I | Active |
| Guardian Safe Bow | K901958 | FDA 510(k) | Class II | Active |
| O.a.s.i. System | K051552 | FDA 510(k) | Class II | Active |
| Storm Mini Screw | K122069 | FDA 510(k) | Class II | Active |
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