FDA UDI
In Commercial Distribution
🇺🇸 United States
S200EML (Contra) Dental Surgery Hand Piece
DI: 00810126043160
·
Model: CA13030007
·
HIOSSEN, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- S200EML (Contra) Dental Surgery Hand Piece
- Primary DI
- 00810126043160
- Version / Model
- CA13030007
- Company Name
- HIOSSEN, INC.
- Labeler DUNS
- 796083090
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-09
- Public Version
- 1
- Public Version Date
- 2026-01-19
- Public Version Status
- New
- Public Device Record Key
- 2393da2d-4b51-48f7-97ef-7c82fd33f240
Device Description
S200EML (Contra) is intended for use in dental oral surgery and dental implant. The dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | Dental | 872.4200 | 1 |
| KMW | Handpiece, Rotary Bone Cutting | Dental | 872.4120 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55847 | Dental implant system | A collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810126043160 | GS1 |