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Esthetic Healing Abutment
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AEHR404Ref AEHS303Ref AEHW504Ref AEHR403Ref AEHR402Ref AEHW502
Identity
- Trade Name
- Esthetic Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Esthetic Healing Abutment EUDAMEDØ3.5/ H=4 FDA UDIØ4.1/ H=4 FDA UDIØ4.1/ H=3 FDA UDIØ3.5/ H=3 FDA UDIØ4.1/ H=2 FDA UDIØ5/ H=2 FDA UDIØ5/ H=4 FDA UDI
- Model / Reference
- AEHR404 EUDAMEDFDA UDIAEHR403 EUDAMEDFDA UDIAEHS303 EUDAMEDFDA UDIAEHR402 EUDAMEDFDA UDIAEHW502 EUDAMEDFDA UDIAEHW504 EUDAMEDFDA UDIAEHS304 FDA UDI
- Description
- Ø3.5/ H=4 FDA UDIØ4.1/ H=4 FDA UDIØ4.1/ H=3 FDA UDIØ3.5/ H=3 FDA UDIØ4.1/ H=2 FDA UDIØ5/ H=2 FDA UDIØ5/ H=4 FDA UDI
Identifiers
- Catalog Number
- AEHS304 FDA UDIAEHR404 FDA UDIAEHR403 FDA UDIAEHS303 FDA UDIAEHR402 FDA UDIAEHW502 FDA UDIAEHW504 FDA UDI
- Primary DI / UDI-DI
- 08806388205240 EUDAMEDFDA UDI08806388205233 EUDAMEDFDA UDI08806388205264 EUDAMEDFDA UDI08806388205226 EUDAMEDFDA UDI08806388205288 EUDAMEDFDA UDI08806388205301 EUDAMEDFDA UDI08806388205271 FDA UDI
- Basic UDI-DI
- 880972899223Q2 EUDAMED
- 510(k) Number
- K203554 FDA UDI
- FDA Product Code
- DZE FDA UDINHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI872.3630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Esthetic Healing Abutment by Megagen Implant Co. Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K203554 also covers:
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (13)
- FDA UDI 7b065888-e452-4401-8b66-e696abdf0b6f 35 fields · synced Jul 31, 2026
- FDA UDI 5ffa087c-e492-48c3-b956-ba80412b108b 35 fields · synced May 29, 2026
- FDA UDI 50b92b99-e7c1-4b9c-a7b2-0f58d61b4f90 35 fields · synced May 30, 2026
- FDA UDI adcd878b-e9f5-44f1-8c33-9b8498fbdd36 35 fields · synced May 30, 2026
- FDA UDI 718bd38a-e422-47b3-b47d-89fe570d1033 35 fields · synced May 30, 2026
- FDA UDI f132af89-186f-4989-b9f5-5a6645b9b8fd 35 fields · synced May 30, 2026
- FDA UDI 1a062e78-1ca6-4b5a-b808-a3d3c7eb8946 35 fields · synced May 30, 2026
- EUDAMED 7db289d4-6edb-4ed3-b18d-6ccb3a5e321f 61 fields · synced Jul 14, 2026
- EUDAMED b8f0d2c3-cd1d-44b2-b0c7-b879deecfd97 61 fields · synced Jul 18, 2026
- EUDAMED c08edff4-748e-4586-a8e8-99fddfbf09fa 61 fields · synced Jul 19, 2026
- EUDAMED 3ac3f928-a285-4c2a-9611-a631131bb921 61 fields · synced Jul 24, 2026
- EUDAMED 03746462-db12-4c63-84ca-9962e79a0fd0 61 fields · synced Jul 25, 2026
- EUDAMED b1679774-b72c-4d7d-8aa3-3d6d25508951 61 fields · synced Jul 31, 2026