FDA UDI
In Commercial Distribution
🇺🇸 United States
Disposable Impression Bite Tray
DI: 08800017902043
·
Model: Side/Posterior
·
DXM CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Disposable Impression Bite Tray
- Primary DI
- 08800017902043
- Version / Model
- Side/Posterior
- Catalog Number
- [BT-1000]
- Company Name
- DXM CO., LTD
- Labeler DUNS
- 688797315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-11
- Public Version
- 1
- Public Version Date
- 2024-06-19
- Public Version Status
- New
- Public Device Record Key
- 6fe26e13-235e-4630-ad74-5e64e8ccbc38
Device Description
Disposable Impression Bite Trays with stainless-steel edge frames used to make an impression of a patient's teeth or alveolar process (bony tooth sockets). Rigid construction with stainless-steel edge frames provides less distortion and firmly holds the impression. DIBT is specifically made thinner and longer for higher accuracy of impressions.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EBH | Material, Impression Tray, Resin | Dental | 872.3670 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16350 | Dental impression tray, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08800017902050 | GS1 | Box | 35 | In Commercial Distribution | |
| Primary | 08800017902043 | GS1 |