FDA UDI
In Commercial Distribution
🇺🇸 United States
palex®
DI: J011602833110
·
Model: 602-833-11
·
DENTAURUM GmbH & Co.KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- palex®
- Primary DI
- J011602833110
- Version / Model
- 602-833-11
- Company Name
- DENTAURUM GmbH & Co.KG
- Labeler DUNS
- 315427286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 5
- Public Version Date
- 2021-11-16
- Public Version Status
- Update
- Public Device Record Key
- 299392f3-713d-4174-9b78-35290f4e5290
Device Description
"palex® click Medium - 10, bent / RPE screw with the “Click” feature to prevent unwanted turning back For effective and reliable rapid palatal expansion by means of fixed appliances. / For further information please visit our website: www.dentaurum.de"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65677 | Orthodontic palate expander screw, bonded | An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J011602833110 | HIBCC |
Customer Contacts
- Phone
- +1(800)523-3946
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- No special storage conditions required