FDA UDI
In Commercial Distribution
🇺🇸 United States
Dental Chair
DI: 07899581340925
·
Model: Syncrus G2
·
Alliage S/A Indústrias Médico Odontológica
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Dental Chair
- Primary DI
- 07899581340925
- Version / Model
- Syncrus G2
- Catalog Number
- 41000008156
- Company Name
- Alliage S/A Indústrias Médico Odontológica
- Labeler DUNS
- 898231451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-25
- Public Version
- 1
- Public Version Date
- 2025-08-04
- Public Version Status
- New
- Public Device Record Key
- 9bf33550-325b-4fed-87c2-cdc913db16b8
Device Description
CADEIRA SYNCRUS G2 P1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KLC | Chair, Dental, With Operative Unit | Dental | 872.6250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47144 | Dental chair, electric | A mains electricity (AC-powered) device designed to support a patient in a seated position to facilitate dental examination, treatment, and/or minor surgery procedures. It is typically adjustable in height to enable healthcare staff to perform procedures while standing. It usually includes head and armrests, a reclining back that may be tilted from a vertical to a horizontal position, and has rotating capabilities; some types can be programmed to several standard positions. Devices intended for dental examination and/or treatment (e.g., lights, irrigation) may be attached as components of the chair, or stand separately as self-supported, wall- or ceiling-mounted units. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07899581340925 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K863016 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -12 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal