FDA UDI
In Commercial Distribution
🇺🇸 United States
Impression Trays Perforated
DI: G429A4290
·
Model: A429
·
MEED SKILL SURGICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Impression Trays Perforated
- Primary DI
- G429A4290
- Version / Model
- A429
- Company Name
- MEED SKILL SURGICAL
- Labeler DUNS
- 645670493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-09
- Public Version
- 1
- Public Version Date
- 2023-01-17
- Public Version Status
- New
- Public Device Record Key
- c83404e5-a1c5-4f95-8457-0ac7f20430be
Device Description
Impression trays are dental instruments which are used to hold the Impression material in place to take a Impression of the tissue surfaces in the oral cavity, the impression trays are mainly used in Prosthodontics and used in Orthodontics to take impression of the Dentulous teeth.
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide, Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHY | Tray, Impression, Preformed | Dental | 872.6880 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35850 | Dental impression tray, reusable | A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G429A4290 | HIBCC |