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FDA 510(k)

IMPLANT, DENTAL, PYROLITE CARBON ENDO.

K-Number: K770440 · 1977-03-15

ApplicantGeneral Atomic Co.
Decision Date1977-03-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPLANT, DENTAL, PYROLITE CARBON ENDO. is the device name listed in this FDA 510(k) record. The listed applicant is General Atomic Co.. It received FDA 510(k) clearance on 1977-03-15 under 510(k) number K770440. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANT, DENTAL, PYROLITE CARBON ENDO.?

IMPLANT, DENTAL, PYROLITE CARBON ENDO. is a medical device that received FDA 510(k) clearance on 1977-03-15. The listed applicant is General Atomic Co.. The 510(k) number is K770440.

When did IMPLANT, DENTAL, PYROLITE CARBON ENDO. receive FDA 510(k) clearance?

IMPLANT, DENTAL, PYROLITE CARBON ENDO. received FDA 510(k) clearance on 1977-03-15, under 510(k) number K770440.

Who is the listed applicant for IMPLANT, DENTAL, PYROLITE CARBON ENDO.?

The FDA 510(k) record lists General Atomic Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT, DENTAL, PYROLITE CARBON ENDO.?

The FDA product code for IMPLANT, DENTAL, PYROLITE CARBON ENDO. is DZE.

Related Clinical Trials

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.

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Other records listing General Atomic Co. 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.

K772304DENTAL IMPLANT, CARBON COATED METAL

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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