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Alpha Dent Implants Dental Implants System

by Alpha Dent Implants GmbH EUDAMED510(k)GUDID

Active European Union and United States

510(k) K240435Ref IAK 5x11.5, IIS 4.2x10, ISPA 3.5x6.75, ISPA 4.0x11.5, ISPA 4.5x4.0, IAK 3.75x6, ISPA 5.0x4.0, IS 3x20, IS 3x10, IS 3x18, IAK 3.3х8, ISPA 4.0x10, ISPA 3.5x16, IS 3x16, IAK 5x10, IIS 4.2x6, IAK 3.3x11.5, IAK 4.2x8, IIS 3.8x8, IAK 4.2x6, IAK 3.3x13, IIS 3.3x11.5, ISPA 4.5x13, ISPA 4.0x16, IAK 6x8, IAK 6x11.5, IAK 3.75x10, IIS 3.3x10, IIS 5x13, IIS 5x8, ISPA 3.5x13, IAK 4.2x10, IAK 4.2x11.5, IAK 5x13, IIS 3.8x13Model Sterility Dental Implant Active Konus, Sterility Dental Implant Slim, Sterility Dental Implant Superior Active

Overview

The Alpha Dent Implants Dental Implants System is a dental implant device designed for the replacement of missing teeth. It integrates into the jawbone to provide stable support for prosthetic teeth, restoring function and aesthetics in patients requiring oral rehabilitation.

This system is supplied sterile for single-use and is intended for use in dental clinics and oral surgery settings. It complies with FDA 510(k) clearance under the Traditional pathway and is authorised under the Medical Device Regulation (MDR). The product code assigned is DZE, and it is manufactured by Alpha Dent Implants GmbH in Pforzheim, Germany.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04060474004757 UDI-DIDate30 Jun 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number4260687SDActiveKonusYJ Basic UDI-DIDate29 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK240435 Date20 Dec 2024ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

No FDA recalls on record, checked 23 Oct 2026.

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Alpha Dent Implants
Generic Name
Screw endosteal dental implant, two-piece
Device Name
Implant Active Konus
Implant Slim
Model / Ref / Catalog
Sterility Dental Implant Active Konus, IAK 5x11.5, Sterility Dental Implant Slim, IIS 4.2x10, Sterility Dental Implant Superior Active, ISPA 3.5x6.75, ISPA 4.0x11.5, ISPA 4.5x4.0, IAK 3.75x6, ISPA 5.0x4.0, IS 3x20, IS 3x10, IS 3x18, IAK 3.3х8, ISPA 4.0x10, ISPA 3.5x16, IS 3x16, IAK 5x10, IIS 4.2x6, IAK 3.3x11.5, IAK 4.2x8, IIS 3.8x8, IAK 4.2x6, IAK 3.3x13, IIS 3.3x11.5, ISPA 4.5x13, ISPA 4.0x16, IAK 6x8, IAK 6x11.5, IAK 3.75x10, IIS 3.3x10, IIS 5x13, IIS 5x8, ISPA 3.5x13, IAK 4.2x10, IAK 4.2x11.5, IAK 5x13, IIS 3.8x13, Implant Superior Active Ø3.5 L16, Implant Superior Active Ø4.0 L16, Implant Superior Active Ø4.5 L13, Implant Superior Active Ø4.0 L11.5, Implant Superior Active Ø4.0 L10, Implant Superior Active Ø3.5 L13, Implant Integral Ø3.3 L11.5, Implant Integral Ø3.3 L10
Primary DI / UDI-DI
04060474004757, 04060474005709, 04060474008793, 04060474008885, 04060474008908, 04060474007604, 04060474008960, 04060474007451, 04060474007406, 04060474007444, 04060474007567, 04060474008878, 04060474012523, 04060474007437, 04060474004740, 04060474007512, 04060474007581, 04060474004689, 04060474007475, 04060474007611, 04060474007598, 04060474005655, 04060474008953, 04060474012530, 04060474007628, 04060474007642, 04060474004658, 04060474005648, 04060474005754, 04060474007543, 04060474008830, 04060474004696, 04060474004702, 04060474004764, 04060474007505
Basic UDI-DI
4260687SDActiveKonusYJ, 4260687SDSlim9N, 4260687SDSuperiorActive22
510(k) Number
FDA Product Code
DZE
EMDN Code
P01020101 Dental implants
GMDN Term
Screw endosteal dental implant, two-piece
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 872.3640
Market of Registration
Germany
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

3 sources · 2 fields differ

FieldEUDAMED510(k)GUDID
Model / ReferenceEUDAMED
Sterility Dental Implant Active Konus
IAK 5x11.5
Sterility Dental Implant Slim
IIS 4.2x10
Sterility Dental Implant Superior Active
ISPA 3.5x6.75
ISPA 4.0x11.5
ISPA 4.5x4.0
IAK 3.75x6
ISPA 5.0x4.0
IS 3x20
IS 3x10
IS 3x18
IAK 3.3х8
ISPA 4.0x10
ISPA 3.5x16
IS 3x16
IAK 5x10
IIS 4.2x6
IAK 3.3x11.5
IAK 4.2x8
IIS 3.8x8
IAK 4.2x6
IAK 3.3x13
IIS 3.3x11.5
ISPA 4.5x13
ISPA 4.0x16
IAK 6x8
IAK 6x11.5
IAK 3.75x10
IIS 3.3x10
IIS 5x13
IIS 5x8
ISPA 3.5x13
IAK 4.2x10
IAK 4.2x11.5
IAK 5x13
IIS 3.8x13
510(k)
n/a
GUDID
Implant Superior Active Ø3.5 L16
Implant Superior Active Ø4.0 L16
Implant Superior Active Ø4.5 L13
Implant Superior Active Ø4.0 L11.5
Implant Superior Active Ø4.0 L10
Implant Superior Active Ø3.5 L13
Implant Integral Ø3.3 L11.5
Implant Integral Ø3.3 L10
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

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Questions

  • What types of dental clinics or settings is the Alpha Dent Implants System intended for use in?

    The Alpha Dent Implants System is specifically designed for use in dental clinics and oral surgery settings where patients require tooth replacement. Its sterile, single-use packaging ensures controlled infection prevention, making it suitable for procedures where precision and hygiene are critical, such as implant placements in the jawbone.

  • How is the Alpha Dent Implants System supplied, and is it reusable?

    The Alpha Dent Implants System is supplied sterile and is intended for single-use only. This design minimizes cross-contamination risks and ensures patient safety, which is particularly important in dental implant procedures where sterility is paramount. Reuse is not recommended or supported by the manufacturer.

  • What regulatory pathways has the Alpha Dent Implants System undergone, and what does that mean for buyers?

    The Alpha Dent Implants System has undergone FDA 510(k) clearance via the Traditional pathway and is authorized under the Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness against legally marketed predicate devices (for the FDA) and meets stringent EU regulatory requirements (for MDR). Buyers can rely on its compliance with both U.S. and European medical device standards.

  • Are there different sizes or models available in the Alpha Dent Implants System, and if so, how are they specified?

    While the provided data does not list specific sizes or models, the Alpha Dent Implants System is designed to accommodate various patient anatomies for tooth replacement. Typically, dental implant systems like this offer a range of diameters, lengths, and thread designs to match individual clinical needs. For exact specifications, buyers should consult the manufacturer’s technical documentation or contact Alpha Dent Implants GmbH directly.

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No