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AmLUJECT DENTAL NDL. 27G X 32MM LONG
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 90080
Identity
- Trade Name
- AmLUJECT DENTAL NDL. 27G X 32MM LONG EUDAMEDAccuject Dental Needles 27G Long FDA UDI
- Generic Name
- Dental syringe needle, single-use FDA UDI
- Device Name
- Dental Needle EUDAMED900805 ; ACCUJECT DENTAL NDL. 27GX32MM LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
- Model / Reference
- 90080 EUDAMEDFDA UDI
- Description
- 900805 ; ACCUJECT DENTAL NDL. 27GX32MM LONG, 100/BX, 1000/CS, 6CS/CRTN FDA UDI
Identifiers
- Catalog Number
- 900805 FDA UDI
- Primary DI / UDI-DI
- 00020221900804 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221900804 EUDAMED
- 510(k) Number
- K861150 FDA UDI
- FDA Product Code
- DZM FDA UDI
- EMDN Code
- A010699 DENTISTRY NEEDLES AND KITS - OTHER EUDAMED
- GMDN Term
- Dental syringe needle, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4730 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 27 Gauge FDA UDILength — 32 Millimeter FDA UDI
AmLUJECT DENTAL NDL. 27G X 32MM LONG by Exelint International, Co. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00020221900804 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b4330319-8658-46b7-a4ee-5a0831280cd1 61 fields · synced Jul 10, 2026
- FDA UDI 7d0f5fd7-9205-460b-9ec9-373cc5279aa0 37 fields · synced May 26, 2026