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Sign in to claim this brandRespire Medical Holding
US
Last updated May 23, 2026
What Respire Medical Holding makes
Respire Medical Holding manufactures orthodontic appliances, including the Respire Pink Series with DentiTrac, Respire Pink Series-Herbst-EF, and Respire Blue Series-EF. These devices are designed for orthodontic treatment, such as space management and jaw alignment, using removable or semi-permanent appliances.
The company’s products fall under FDA Class II devices and are listed via 510(k) clearance. The manufacturer is based in 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 Respire Medical Holding manufacture?
Respire Medical Holding specializes in orthodontic appliances. Their devices include the Respire Pink Series with DentiTrac, Respire Pink Series-Herbst-EF, and Respire Blue Series-EF. These products are designed for orthodontic treatment, such as managing dental spacing and aligning the jaw using removable or semi-permanent appliances.
Where is Respire Medical Holding based?
Respire Medical Holding is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.
Which regulatory registries or databases list Respire Medical Holding’s devices?
Respire Medical Holding’s devices are listed in the FDA’s 510(k) clearance registry. This clearance process is required for Class II devices in the U.S., ensuring they meet regulatory requirements before commercial distribution.
How are Respire Medical Holding’s devices classified under U.S. regulations?
Respire Medical Holding’s devices fall under FDA Class II classification. This classification applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as orthodontic appliances.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Blue Series - EF | SB030US | FDA UDI | Class II | Active |
| Blue Series - H/S | SB020US | FDA UDI | Class II | Active |
| Pink Series - H/S | SP020US | FDA UDI | Class II | Active |
| Respire Pink EF+ | SPP030US | FDA UDI | Class II | Unknown |
| Pink Series - EF | SP030US | FDA UDI | Class II | Active |
| Respire Pink+ H/S | SPP020US | FDA UDI | Class II | Unknown |
| Respire Pink+ Hard | SPP000US | FDA UDI | Class II | Unknown |
| Respire Pink AT EF | SPAT030US | FDA UDI | Class II | Active |
| Respire Pink Series Micro with DentiTrac | SPMD000US | FDA UDI | Class II | Active |
| Pink Series - Hard | SP000US | FDA UDI | Class II | Active |
| Respire Pink AT Hard/Soft | SPAT020US | FDA UDI | Class II | Active |
| Pink Micro - EF | SPM030US | FDA UDI | Class II | Active |
| Respire Pink+ H/S with DentiTrac | SPPD020US | FDA UDI | Class II | Unknown |
| Respire Pink+ Hard with DentiTrac | SPPD000US | FDA UDI | Class II | Unknown |
| Pink Micro - Hard | SPM001US | FDA UDI | Class II | Active |
| Respire Pink Series Micro H/S with DentiTrac | PSMD020US | FDA UDI | Class II | Active |
| Respire Pink Series EF with DentiTrac | SPD030US | FDA UDI | Class II | Active |
| Blue + Hard | SBP000US | FDA UDI | Class II | Active |
| Respire Pink AT Hard | SPAT000US | FDA UDI | Class II | Active |
| Blue + Hard/Soft | SBP020US | FDA UDI | Class II | Active |
| Pink Micro - H/S | SPM020US | FDA UDI | Class II | Active |
| Respire Pink Series with DentiTrac - H | SPD000US | FDA UDI | Class II | Active |
| Blue EF + Hard/Soft | SBP040US | FDA UDI | Class II | Active |
| Blue Series - Hard | SB000US | FDA UDI | Class II | Active |
| Blue EF + Hard | SBP030US | FDA UDI | Class II | Active |
| Respire Pink EF+ with DentiTrac | SPPD030US | FDA UDI | Class II | Unknown |
| Respire Pink Series H/S with DentiTrac | SPD020US | FDA UDI | Class II | Active |
| Respire Pink Series EF Micro with DentiTrac | SPMD030US | FDA UDI | Class II | Active |
| Respire Pink Series with DentiTrac | K170692 | FDA 510(k) | Class II | Active |
| Respire Pink Series-Herbst-EF | K150572 | FDA 510(k) | Class II | Active |
| Respire Pink AT (Hard, Hard/Soft, EF) | K192127 | FDA 510(k) | Class II | Active |
| Respire Blue Series-EF | K152292 | FDA 510(k) | Class II | Active |
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