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FDA 510(k)

ACE DENTAL IMPLANT CUSTOM SURGICAL PACK

K-Number: K922650 · 1994-01-10

ApplicantAce Surgical Supply Co., Inc.
Decision Date1994-01-10
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACE DENTAL IMPLANT CUSTOM SURGICAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Ace Surgical Supply Co., Inc.. It received FDA 510(k) clearance on 1994-01-10 under 510(k) number K922650. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACE DENTAL IMPLANT CUSTOM SURGICAL PACK?

ACE DENTAL IMPLANT CUSTOM SURGICAL PACK is a medical device that received FDA 510(k) clearance on 1994-01-10. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K922650.

When did ACE DENTAL IMPLANT CUSTOM SURGICAL PACK receive FDA 510(k) clearance?

ACE DENTAL IMPLANT CUSTOM SURGICAL PACK received FDA 510(k) clearance on 1994-01-10, under 510(k) number K922650.

Who is the listed applicant for ACE DENTAL IMPLANT CUSTOM SURGICAL PACK?

The FDA 510(k) record lists Ace Surgical Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE DENTAL IMPLANT CUSTOM SURGICAL PACK?

The FDA product code for ACE DENTAL IMPLANT CUSTOM SURGICAL PACK is EIA.

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Other records listing Ace Surgical Supply Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMK092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OXK073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XXK080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XXK061397ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, MK051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

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Related Devices (Code: EIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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